Clinical trial NCT04434131
Conditions: COVID-19
Sponsor: University of New Mexico
Start date: 2020-04-28; Completion date: 2021-03-12
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open label pilot study designed to provide access to treatment with investigational convalescent plasma and assess the relationship between NAb titers in the investigational convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients with COVID-19.

Detailed description:
Primary objectives are as follows:

1. To provide access to treatment with investigational convalescent plasma to inpatients with documented COIVD-19 infection
2. To measure NAb titers in an aliquot of the CP administered, to measure the volume of CP administered, and determine whether there is a correlation between the NAb dose (in NAb units/kg body weight, where a unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the volume in ml) and change or lack of change when comparing pre-treatment and day one NAb titers.

Secondary, exploratory objectives are as follows:

1. To evaluate the safety of convalescent plasma (CP) administration in hospitalized COVID-19 patients
2. To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples before and on days 3, 7, and 14 after CP transfusion
3. To perform genomic analysis of the SARS-CoV-2 from patients before and after treatment with CP transfusion
4. Determine cumulative incidence of disease severity (transfer to ICU, type of respiratory support, LOS, and mortality)

Arms: arm 1: The investigational product is anti-SARS-CoV-2 convalescent plasma obtained from former patients identified as having recovered from COVID-19 and obtained by Vitalant from local and national donors following national blood donation guidelines. All subjects receive the convalescent plasma.
Interventions: intervention 1: Convalescent Plasma
Intervention descriptions: intervention 1: Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent plasma collected from a single donor who recovered from COVID-19.

Protocol documents:
Prot_SAP_001.pdf: 
PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 1 of 30
Version: 1 Date: 5/04/2020
PRINCIPAL INVESTIGATOR:
Name: Michelle Harkins
Department: Internal Medicine-Pulmonary Critical Care
ADMINISTRATIVE CONTACT:
Name  Greg Trejo
Department  Internal Medicine
VERSION NUMBER:
Version 1.0 
DATE:
05.04.2020
REGULATORY FRAMEWORK:
Please indicate all that apply:
☐
DOD (Department of Defense)
☐
DOE (Department of Energy)
☐
DOJ (Department of Justice)
☐
ED (Department of Education)
☐
EPA (Environmental Protection Agency)
☐
FDA (Food and Drug Administration)
☐
HHS (Department of Health and Human Services)
☐
VA
☒
Other:      
FUNDING:
No funding available
CLINICAL TRIALS
Is this a clinical trial per the NIH definition of a Clinical Trial?   ☒ Yes   ☐ No
NIH Definition of a Clinical Trial: 
A research study in which one or more human subjects are prospectively assigned to


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 2 of 30
Version: 1 Date: 5/04/2020
one or more interventions. An "intervention" is defined as a manipulation of the subject or 
subject’s environment for the purpose of modifying one or more health-related biomedical or 
behavioral processes and/or endpoints. Examples include: drugs/small molecules/compounds; 
biologics; devices; procedures (e.g., surgical techniques); delivery systems (e.g., telemedicine, 
face-to-face interviews); strategies to change health-related behavior (e.g., diet, cognitive 
therapy, exercise, development of new habits); treatment strategies; prevention strategies; 
and, diagnostic strategies (which may include placebo or other control) to evaluate the effects 
of those interventions on  health-related biomedical or behavioral outcomes. 
Use the following four questions to determine the difference between a clinical study and a 
clinical trial:       
1) Does the study involve human participants? ☒ Yes   ☐ No
2) Are the participants prospectively assigned to an intervention? ☒ Yes   ☐ No
3) Is the study designed to evaluate the effect of the intervention on the participants? ☒ 
Yes   ☐ No 
4)  Is the effect being evaluated a health-related biomedical or behavioral outcome? ☒ Yes   
☐ No
Note that if the answers to the 4 questions are yes, your study meets the NIH definition of a 
clinical trial, even if… 
●
You are studying healthy participants
●
Your study does not have a comparison group (e.g., placebo or control)
●
Your study is only designed to assess the pharmacokinetics, safety, and/or maximum 
tolerated dose of an investigational drug
●
Your study is utilizing a behavioral intervention
If yes to all 4 questions, please confirm that the research team is familiar with and agrees to 
comply with the investigator requirement to register the study on the ClinicalTrials.gov 
database. Additionally, the approved consent document(s) must be uploaded to the 
ClinicalTrials.gov database    ☒ Yes   ☐ No 
For any assistance with registration of your trial or the requirements, please contact HSC-
CTSCResearchConcierge@salud.unm.edu 


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 3 of 30
Version: 1 Date: 5/04/2020
Table of Contents
1.
Objectives
6
2.
Background
6
3.
Study Design
6
4.
Inclusion and Exclusion Criteria
6
5.
Number of Subjects
6
6.
Study Timelines
7
7.
Study Endpoints
7
8.
Research Setting
7
9.
Resources Available
7
10.
Prior Approvals
8
11.
Multi-Site Research
8
12.
Study Procedures
9
13.
Data Analysis
10
14.
Provisions to Monitor the Data to Ensure the Safety of Subjects
10
15.
Withdrawal of Subjects
10
16.
Data Management/Confidentiality
11
17.
Data and Specimen Banking
12
18.
Risks to Subjects
13
19.
Potential Benefits to Subjects
13
20.
Recruitment Methods
13
21.
Provisions to Protect the Privacy Interests of Subjects
14
22.
Economic Burden to Subjects
14
23.
Compensation
15
24.
Compensation for Research-Related Injury
15
25.
Consent Process
15
26.
Documentation of Consent
18
27.
Study Test Results/Incidental Findings
19
28.
Sharing Study Progress or Results with Subjects
19
29.
Inclusion of Vulnerable Populations
20
30.
Community-Based Participatory Research
21
31.
Research Involving American Indian/Native Populations
21
32.
Transnational Research
21
33.
Drugs or Devices
22
34.
Principal Investigator’s Assurance
22
35.
CHECKLIST SECTION
24
36.
Partial Waiver of Consent for Screening/Recruitment
24
37.
Partial Waiver of HIPAA Authorization for Screening/Recruitment
25
38.
Waiver of Documentation of Consent
25
39.
Alteration of Consent
26
40.
Full Waiver of Consent/Parental Permission
27
41.
Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs)28


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 4 of 30
Version: 1 Date: 5/04/2020
42.
Full Waiver of HIPAA Authorization (Checklist)
28
43.
Other Waiver Types (Checklist)
29
44.
Vulnerable Populations (Checklist)
29
45.
Medical Devices (Checklist)
35
46.
Export Control (Checklist)
36
47.
Data Transfer/Sharing (Checklist)
36
48.
Specimen Transfer/Sharing (Checklist)
37


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 5 of 30
Version: 1 Date: 5/04/2020
1. Objectives
1.1. Primary 
1.1.1. To provide access to treatment with investigational convalescent plasma 
to inpatients with documented COIVD-19 infection  
1.1.2. To measure NAb titers in an aliquot of the CP administered, to measure 
the volume of CP administered, and determine whether there is a 
correlation between the NAb dose (in NAb units/kg body weight, where a 
unit is the reciprocal of the endpoint NAb titer in the CP multiplied by the 
volume in ml) and change or lack of change when comparing pre-treatment 
and day one NAb titers.  
1.2. Secondary, exploratory objectives
1.2.1. To evaluate the safety of convalescent plasma (CP) administration in 
hospitalized COVID-19 patients 
1.2.2. To evaluate viral shedding of SARSCoV-2 in nasopharyngeal or nasal samples 
before and on days 3, 7, and 14 after CP transfusion 
1.2.3. To perform genomic analysis of the SARS-CoV-2 from patients before and after 
treatment with CP transfusion 
1.2.4.
Determine cumulative incidence of disease severity (transfer to ICU, type of 
respiratory support, LOS, and mortality) 
2. Background
Passive antibody treatment involves the administration of antibodies against a specific infection 
to a susceptible individual to treat or ameliorate the severity of the disease caused by the 
infectious agent. Plasma from patients that have recovered from the infection is harvested and 
administered to the non-immune. The use of this modality of treatment dates back to the 
1890´s, but it popularity decreased during the antibiotic era.(Casadevall, 2020)
During the current SARSCoV-2 pandemic, with its associated high mortality and morbidity and 
the lack of demonstrated and effective treatment or vaccine, the induction of immunity with the 
transfusion of convalescent plasma offers a therapeutic alternative. 
Convalescent plasma was studied during the SARS epidemic in 80 patients in Hong Kong.(Cheng 
2005)  Those treated before day 14 from had improved prognosis defined by discharge from 
hospital before day 22, consistent with the notion that earlier administration is more likely to be 
effective. There is also anecdotal information on the use of convalescent serum in seriously ill 
individuals. Three patients with SARS in Taiwan were treated with 500 mL convalescent serum, 
resulting in a reduction in serum virus titer, and each survived (Yeh 2005) 


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 6 of 30
Version: 1 Date: 5/04/2020
There are reports that convalescent serum was used for therapy of patients with COVID-19 in 
China during the current outbreak. In an open label study, 5 patients received transfusion with 
convalescent plasma with a SARS-CoV-2– specific antibody (IgG) binding titer greater than 1:1000 
(end point dilution titer, by enzyme-linked immunosorbent assay [ELISA]) and a neutralization 
titer greater than 40 (end point dilution titer) that had been obtained from 5 patients who 
recovered from COVID-19 (Shen 2020). Convalescent plasma was administered between 10 and 
22 days after admission. In this preliminary uncontrolled case series of 5 critically ill patients with 
COVID-19 and ARDS, administration of convalescent plasma containing neutralizing antibody was 
followed by improvement in their clinical status.
In another study, 10 patients were treated with one dose of 200 mL convalescent plasma (CP) 
derived from recently recovered donors with the neutralizing antibody titers above 1:640 in 
addition to maximal supportive care and antiviral agents Duan 2020). The clinical symptoms were 
significantly improved along with increase of oxyhemoglobin saturation within 3 days. Several 
parameters tended to improve as compared to pre-transfusion, including increased lymphocyte 
counts (0.65×109/L vs. 0.76×109/L) and decreased C-reactive protein (55.98 mg/L vs. 18.13 
mg/L). Radiological examinations showed varying degrees of absorption of lung lesions within 7 
days. In none of these two trials serious adverse events associated with the use of CP were 
reported.
More recently, the FDA has endorsed the use of CP under an emergency IND, specific guidance 
on 
donor 
and 
potential 
recipient 
selection 
has 
been 
published. 
(https://www.fda.gov/media/98616/download)
Little is known about how the treatment with CP affects the recipient’s immune response to the 
infection with SARS-CoV-2. What levels of neutralizing antibodies (NAbs) are obtained in 
patients transfused? Is there association between neutralizing antibody titers and clinical 
outcomes? In the study by Duan et al, with 10 patients treated with CP, the neutralizing 
antibody titers of five patients increased and four patients remained at the same level after CP 
transfusion. However, neither study performed a comparison between the NAb dosing adjusted 
for body weight versus resulting NAb levels in recipients.  
In light of limited availability of CP and the urgent need for promising therapies for COVID-19, it 
will not be initially feasible to measure NAb titers in the convalescent plasma (CP) prior to 
plasma administration or to adjust the volume of CP to be administered based on NAb titer in 
the CP or the body weight or plasma volume of the recipient.  However, while this study does 
not involve administration of plasma with known NAb titer, information gained from the 
current study may help inform dosing in the future, including in potential dosing modifications 
that could be submitted via a protocol modification.    


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 7 of 30
Version: 1 Date: 5/04/2020
The correlation between the levels or titers of neutralizing antibodies after CP transfusion and 
viral shedding has not been sufficiently explored. Are certain levels of neutralizing antibodies 
associated with viral clearance? In the study by Duan et al., the viral load was undetectable 
after transfusion in seven patients who had previous viremia (Duan et al.) We propose to 
monitor viral shedding in respiratory secretions after CP transfusion. The presence of the virus 
is relevant for transmission, especially in the hospital setting.
3. Study Design
This is an open label pilot study designed to provide access to treatment with investigational 
convalescent plasma and assess the relationship between NAb titers in the investigational 
convalescent plasma compared to changes in NAb levels in the recipient in hospitalized patients 
with COVID-19.  
4. Inclusion and Exclusion Criteria
Inclusion Criteria for Enrollment
1. Patients must be 18 years of age or older.
2. Hospitalized with COVID-19 respiratory symptoms and confirmation via COVID-19 
SARS-CoV-2 RT-PCR testing. If COVID-19 test results are pending or done at 
enrolment, test results must be positive prior to administration of convalescent 
plasma.
3. Patient (or legally authorized representative, LAR) is willing and able to provide 
written informed consent and comply with all protocol requirements. 
4. For patients unable to consent, consent by the legally authorized representative 
(LAR) may be obtained by phone.
Exclusion Criteria
1. Female subjects with positive pregnancy test or breastfeeding. 
2. Receipt of pooled immunoglobulin in past 30 days. 
3. Contraindication to transfusion or history of prior severe allergic reactions to 
transfused blood products
4. On ECMO or in refractory shock at entry
5. Number of Subjects
This pilot aims to explore safety and measure antibody levels in patients treated with CP. 
We aim to enroll 30 subjects to ensure the estimate of neutralizing antibodies to be within 
20% margin of error.


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 8 of 30
Version: 1 Date: 5/04/2020
6. Study Timelines
Hospitalized patients will be enrolled as soon as their COVID-19 diagnosis is confirmed, 
using approved diagnostic methods, and will be followed until hospital discharge or death.  
Patient enrollment will start immediately after IRB approval. We anticipate a 3-month 
enrollment. The study will continue for another 24-months after the last enrollment during 
which we will be able to process and analyze data, and disseminate findings. 
7. Study Endpoints
7.1. Primary endpoint:
7.1.1. Titers of SARS-CoV-2 neutralizing antibodies measured by focus reduction 
neutralization test (FRNT) at days 0 (pre-transfusion), 1, 3, 7 and 14 days of CP 
transfusion.
7.1.2. Availability of convalescent plasma
7.2. Secondary endpoints:
Clinical outcomes:
7.2.1
Serious adverse events
7.2.2
SARCoV-2 viral shedding in nasopharyngeal samples determined by RT-PCR
7.2.3
Genomic variations of SARS-CoV-2 before and after CP transfusion
7.2.4
Transfer to ICU
7.2.5
Type and duration of respiratory support (and other ICU support including 
ECMO, CRRT) in ICU 
7.2.6
Cardio-circulatory arrest (at any time)
7.2.7
ICU mortality and LOS
7.2.8
Hospital mortality and LOS
7.2.9
Ventilator-free days
7.2.10 In hospital mortality
7.2.11 Titer of other functions of antibodies, including antibody-dependent cell-
mediated and complement-dependent cytotoxicity
7.3. Safety Endpoints:
7.3.1 Rapid deterioration of respiratory or clinical status on transfusion of SARS-CoV-2 
convalescent plasma.
7.3.2 Cumulative incidence of serious adverse events during the study period: febrile 
non-hemolytic transfusion reaction, allergic transfusion reaction, transfusion related 
acute lung injury (TRALI), transfusion associated circulatory overload (TACO), 


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 9 of 30
Version: 1 Date: 5/04/2020
transfusion related infection, hemolytic transfusion reaction or evidence of antibody 
dependent enhancement of infection (ADE). 
8. Research Setting
The study will be conducted in the University of New Mexico Hospital. Patients admitted to 
the COVID-19 units including the emergency department, regular wards and intensive care 
units will be enrolled. Patients will be identified from the TriCore Laboratory testing result 
portal available to the research team or upon notification by providers in the participating 
institutions. Approval by the treating provider will be requested before patient enrollment 
and consent.
There is no external sponsor for this research.  Immune assays and genomic studies will be 
performed utilizing existing resources within the Bradfute and Domman laboratories in the 
Center for Global Health.  
SARS-CoV-2 neutralizing antibody titers will be measured using the focus reduction 
neutralization test (FRNT) in Dr. Steven Bradfute’s Laboratory, Center for Global Health 
(CGH), UNMHSC.  Neutralization assays will be conducted using methods already 
established in the Bradfute laboratory.  Briefly, serial dilutions of plasma will be incubated 
with 50-100 pfu of SARS-CoV-2 at equal volumes for 1 hour and added to Vero E6 cells, 
followed by overlaying with agarose.  Two days later cells will be fixed with 4% 
formaldehyde, stained with crystal violet, and plaques will be counted.  Other functions of 
antibody, including antibody-dependent cell-mediated cytotoxicity and complement-
dependent cytotoxicity, will be ascertained using established methods.
Virus sequencing will be performed in the laboratory of by Dr. Daryl Domman in the 
Center for Global Health using the PCR-based NGS sequencing protocol described by 
the ARTIC Network https://artic.network/ncov-2019
9. Resources Available
9.1. Principal investigator and co-investigators are experienced Pulmonary, Critical Care, 
Infectious Disease ID Pharmacists, Virologist or Transfusion Medicine specialists with 
ample experience in conducting clinical trial and with the use of CP in previous clinical 
studies (GM):
9.1.1. Michelle Harkins, MD, is a Pulmonary and Critical Care Medicine specialist and is 
the Chief of the Division of Pulmonary at UNMH
9.1.2. Nestor Sosa, MD, is an Infectious Disease Attending and is the Chief of Infectious 
Diseases at UNMH.


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 10 of 30
Version: 1 Date: 5/04/2020
9.1.3. Gregory Mertz, MD, is an infectious diseases specialist at UNM with a history of 
NIAID-sponsored research (GMertz, PI)  involving collection of plasma from 
survivors of hantavirus cardiopulmonary syndrome (HCPS) in New Mexico and 
Chile, development and evaluation of FRNT and BSL-2 based pseudovirion assays 
for measurement of ANDV neutralizing antibody titers, and evaluation of the safety 
of immune plasma administration for HCPS (Vial P, 2015),
9.1.4. Steven Bradfute, PhD, is a basic scientist whose research area is viral infections 
and immune response.
9.1.5. Jay Raval, MD, is a Transfusion Medicine specialist and is Senior Director of 
Transfusion Medicine and Therapeutic Pathology at UNM.
9.1.6. Daryl Domman, PhD, is an Assistant Professor at CGH with expertise in infectious 
disease genomics, bioinformatics, and genomic epidemiology.
9.1.7. Douglas J Perkins, PhD, is a Professor of Medicine and Director, Center for Global 
Health, University of New Mexico. Dr. Perkins has studied the pathogenesis of 
infectious diseases for the past 23 years, including in Kenya for the last 18 years, 
and sub-Saharan Africa for the 23 years. 
9.1.8. Keenan Ryan PharmD, is an Infectious Diseases trained pharmacist at UNM
9.1.9. Yiliang Zhu, PhD, professor at the Division of Epidemiology, Biostatistics and 
Preventive Medicine is a biostatistician and data scientist.  
9.2. The treating provider (Hospital Medicine or Pulmonary Critical Care) in the respective 
COVID-19 units will be responsible for medical decision-making, ordering and 
evaluating the participants.
9.3. Prior to enrollment, availability of the study product (SARS-CoV-2 convalescent plasma) 
will be verified by the study team in collaboration with our blood bank.  
9.4. Study agents will be procured and stored at UNMH blood banking the participating 
hospitals. Donor selection and harvest, labeling and shipment of the study agent will be 
performed by Vitalant.
9.5. The subjects will receive the study agent while hospitalized in our institutions.
9.6. All research specified laboratory testing will be performed in CGH laboratories.
10. Prior Approvals
10.1. Departmental Scientific Review is attached. 
11. Multi-Site Research: 
11.1.
Not Applicable this trial will be conducted at UNMH. 
12. Study Procedures 


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 11 of 30
Version: 1 Date: 5/04/2020
12.1.
Potential subjects will be identified by reviewing the registry of +SARSCoV2 
RTPCR testing (at TRICORE laboratory) in hospitalized patients.
12.2.
Eligibility of the potential study participants will be identified by their treating 
providers (Hospital Medicine and Intensive Care Unit). The treating providers will notify 
representatives of the research team. Members of the research team will verify the 
eligibility of the potential subjects and will obtain informed consent from them or their 
LAR. 
12.3.
Once the participant or their LAR gives their written informed consent, 
the research team will notify the treating provider so they can place the medical 
order for the investigational products. If LAR consented via phone, a copy of the 
consent form will be mailed to LAR. 
12.4.
The protocol specific activities are detailed in Table 1
12.5.
Treatment
Subjects will receive the convalescent plasma.
Study drug: The investigational product is anti-SARS-CoV-2 convalescent plasma 
obtained from former patients identified as having recovered from COVID-19 
and obtained by Vitalant from local and national donors following national blood 
donation guidelines. These donors will be cleared for blood donation like any 
other volunteer blood donor and samples will have been screened for 
transfusion-transmitted infections (e.g. HIV, HBV, HCV, WNV, HTLV-I/II, T. cruzi, 
ZIKV) both through the use of the uniform donor questionnaire and FDA 
mandated blood donor screening tests. This single-donor plasma product will 
have been collected using apheresis technology and in accordance with standard 
FDA and blood bank protocols.
A 1ml of aliquot of anti-SARS-CoV-2 plasma will be saved for NAb titer measurement by 
FRNT (as mention in section 8.) in the CGH laboratory and the total volume of plasma 
administration will be recorded.
12.5.1. Study subjects will receive 1 unit (200mL) of SARS-CoV-2 convalescent 
plasma collected from a single donor who recovered from COVID-19.  
12.5.2. The anti-SARS-CoV-2 convalescent plasma will be in standard plasma 
blood unit bags, anticoagulated with a citrate-based anticoagulant (ACD-A, 
CP2D, et cetera), labeled with a specific ISBT product code, and stored in 
the UNM Blood Bank per FDA, AABB, and CAP protocols. Plasma transfusion 
will be administered over no more than four hours.   
Table 1: Schedule of Events


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 12 of 30
Version: 1 Date: 5/04/2020
Study period
Screen
Baseline
Transfusion
Follow-up
Day
-1 to 0
0
0
1
3
7
14
Eligibility
Informed consent
x
 
 
 
 
 
 
 
Demographic and 
Medical history
x
 
 
 
 
 
 
 
SARS-CoV-2 RT-PCR for 
eligibility
x
 
 
 
 
 
 
 
Pregnancy test
x
 
 
 
 
 
 
 
Type and screen
x
 
 
 
 
 
 
 
Study Agent Administration
Plasma Transfusion
 
 
x
 
 
 
 
 
Study Procedures
 
 
 
 
 
 
 
 
Vital signs
x
x
xxxx[1]
x
x
x
x
 
Physical assessment
x
 
x
x
 
x
 
 
Symptom screen
x
x
x
x
x
x
x
Concomitant 
medications
x
x
x
 
 
 
 
 


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 13 of 30
Version: 1 Date: 5/04/2020
Adverse event 
monitoring
 
x
x
x
x
x
x
Laboratory testing
SARS-CoV-2 RT-PCR[2] 
and Genomic analysis
 
x
 
 
x
x
x
 
SARS-CoV-2 
neutralizing antibody
 
x
 
x
x
x
x
 
Secondary End point 
registration (clinical 
outcome)
 
 
 
 
 
 
 
1. Vital sign testing: Immediately prior to infusion, 10-20 minutes after start of infusion, at completion of infusion 
and 30-60 minutes after the end of the infusion
2. Sampling can include nasopharyngeal, nasal or oropharyngeal swabs.
13. Data Analysis
13.1.1. We will determine whether there is a correlation between the NAb dose 
(in NAb units/kg body weight, where a unit is the reciprocal of the endpoint 
NAB titer in the CP multiplied by the volume in ml) and change or lack of 
change when comparing pre-treatment and day one NAb titers.  We will 
also compare changes in pre- and post-treatment NAb titers based on NAb 
dosing calculated in units/BSA and units/calculated plasma volume to see if 
either measurement provides a better prediction of changes in NAb titers in 
recipients.    
13.2.
Data analysis will be limited to hospitalized subjects with respiratory symptoms 
and laboratory confirmation of SARS-CoV-2 infection by detection RNA in upper or 
lower respiratory samples (nasal or oral swabs or endotracheal fluid) or blood or by 
detection of NAb in serum.  Subjects without laboratory-confirmed COVID 19 will be 
excluded from analysis.  
Neutralizing antibody titers in the patient’s first blood sample (day 0) will be compared 
by rank sum (Wilcoxon) test between patients who develop any of the secondary 


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 14 of 30
Version: 1 Date: 5/04/2020
clinical end-points and patients who do not develop these secondary endpoints. The 
same comparison will be performed to evaluate NAb titers with other parameters such 
as age >65 and <65, presence or absence of diabetes, or presence or absence 
hydroxychloroquine therapy. These analyses of day 0 Nab titers aim to characterize 
patient heterogeneity in Nab titers in relationship to patient demographic and clinical 
characteristics.   
We will also analyze the association between NAb titers at day 0 with duration of viral 
shedding, duration of hospitalization and duration of intubation and other clinical 
parameters.
Our primary endpoint for statistical analysis is changes in NAb titers at day 1, 3, 7, and 
14 from the entry level (day 0).  Our primary hypothesis is that Nab titers will increase 
post-transfusion in positive correlation with transfused volume of convalescent plasma 
when adjusted for NAb titer in the convalescent plasma. We will use repeated 
measurements analysis of variance (ANOVA) or analysis of covariance (ANCOVA) when 
controlling for other factors (e.g. use of hydroxychloroquine) for initial exploration of 
the association with the transfusion volume of convalescent plasma. A more advanced 
approach is to use nonlinear regression models with random effects to characterize the 
trajectory of Nab titers over the course of 14 days. This latter approach can effectively 
characterize individual-specific trajectory in Nab titers in relation to convalescent 
plasma, and at the same time quantify between-patients variation, thereby improving 
statistical power. This mixed-effects nonlinear regression modeling approach is also 
capable of adjusting for other factors as appropriate (e.g. patient age). We will also 
conduct post-hoc analysis of change in Nab titers from day 0 to a specific day (day 1, 3, 
7, or 14) post transfusion of convalescent plasma when appropriate.   Better 
understanding and better characterization of the relationship between Nab titers and 
amount of convalescent plasma transfusion adjusted for NAb titer in the convalescent 
plasma will inform standardized dosage for future study.   
In the absence of a comparison group, we will use descriptive statistics to report other 
parameters of interest (e.g. secondary outcomes), including the use of mean (SD), 
frequency (%) and their confidence interval. When appropriate, we will also report 
association between a parameter of interest and a factor of clinical relevance (e.g. 
duration of shading and underlying comorbidities, Nab titers at a specific post-
transfusion day and underlying comorbidities, Nab titers at a specific post-transfusion 
day and secondary outcomes such as transfer to ICU or hospital death). This analysis 
will utilize odds ratio and Fisher’s test for dichotomous variables, and Wilcoxon test a 
continuous variable. 
We will conduct interim analysis after the first 10 patients complete the study. Based 
on the interim analysis results we may consider submitting a protocol amendment 
requesting adjustment our patient recruitment or CP dosing.


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 15 of 30
Version: 1 Date: 5/04/2020
Given that we have a large number of clinical parameters of potential interest and a small sample 
of 30 patients, we do not have the statistical power or data depth for all analyses. The focus of 
our analysis is on the primary outcome and primary hypothesis. Much of the analyses of 
secondary outcomes are of the nature of exploration. We will adjust for multiplicity of 
comparisons (e.g. associations) using False Discovery Rate (FDR) in reporting our findings.  
13.3. Sample size.  A sample size determination is less plausible for this pilot study since we 
aim to establish the effect size of convalescent plasma transfusion on Nab titers. 
However, we will conduct a post-hoc statistical power analysis to determine the actual 
power with the sample we obtain. 
14. Provisions to Monitor the Data to Ensure the Safety of Subjects
14.1.
A DSMB will be convened to include clinicians specializing in clinical trials, 
transfusion medicine and biostatisticians. The roster will be provided in a Modification 
for HRRC approval once the DSMB has been created.
14.2.
The safety information that will be collected and monitored as follows: reports 
of rapid deterioration of respiratory or clinical status on transfusion of SARS-CoV-2 
convalescent plasma and cumulative incidence of serious adverse events during the 
study period: febrile non-hemolytic transfusion reaction, allergic transfusion reaction, 
transfusion related acute lung injury (TRALI), transfusion associated circulatory 
overload (TACO), transfusion related infection, and hemolytic transfusion reaction.
14.3.
Review of data after 10 participants have been enrolled. 
14.4.
Considering the novelty and rapidly changing situation of the COVID-19 
pandemic, the investigators will review relevant publications that may help inform 
decisions related to the efficacy and safety of the investigational products.
14.5.
The occurrence of any serious adverse event will be notified to the HRRC in 
accordance with GCP regulations. An analysis of all adverse events will be presented 
with the analysis of the first 10 patients enrolled and periodically thereafter. 
14.6.
The conditions that would trigger a suspension or termination of the research 
(i.e., stopping rules), are as follows:
a. If available published information convincingly reports non-efficacy or significant 
safety concerns with the use of SARS-CoV-2 convalescent plasma.
b. If an unexpectedly high incidence of serious adverse events judged to be related to 
SARS-CoV-2 convalescent plasma is detected in these critically ill COVID-19 
patients during the trial in the clinical judgetment of the investigators 
compared to that expected in similarly ill patients receiving normal donor 
plasma in the clinical judgement of the investigators.


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 16 of 30
Version: 1 Date: 5/04/2020
c. If there is an unanticipated safety signal, stopping the study will be considered.
14.7.
Findings will be reported to the HRRC within 5 business days and to the FDA 
accordingly. A preliminary analysis of the study end points will be performed after 10 
patients have been enrolled and end-points reached. The results will be presented to 
the HRRC and investigators.
15. Withdrawal of Subjects
15.1.
Subjects will be withdrawn if the PI determines, in consultation with the treating 
clinician(s) that continuation in the study is not in the participant’s best interest. 
Subjects may also withdraw (or be withdrawn by their LAR at their request at any time 
during their participation in the study by contacting a member of the study team.
15.2.
If a patient develops a serious adverse event that may be probably or definitely 
related to the CP, during the infusion, that may trigger the discontinuation of the 
offending drug.
15.3.
If a participant is withdrawn from the study, chart review will continue to be 
performed to track the participant’s clinical outcomes.
15.4.
Data and specimens collected before withdrawal will not be removed from the 
study.
16. Data Management/Confidentiality
16.1.
Participants will be assigned a randomly generated study ID that will be linked to 
identifiers (MRN, DOB) in a linking table to be kept separate from the research data. 
Data and specimens will be labelled with the study ID only.
16.2.
Only HRRC-approved members of the study team who have the appropriate 
training will have access to the data and identifiers.
16.3.
Data will be entered into REDCap on a password-protected computer using a 
secure network.
16.4.
Any hard copy records/data will be kept in a locked file cabinet in the locked 
office of a designated member of the study team
16.5.
Once data collection is complete, data will be de-identified by destruction of the 
linking table. Study records will be kept for 6 years past study closure.
17. Data and Specimen Banking 
Not Applicable 
18. Risks to Subjects


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 17 of 30
Version: 1 Date: 5/04/2020
18.1 Published data on convalescent antibody administration in SARS (Cheng 2005 and 
Yeh 2005) and SARS and MERS (Mair-Jenkins 2015), and preliminary data on 
convalescent plasma administration in COVID-19 (Shen 2020 and Duan 2020), also 
suggests that CP is safe and well tolerated.  
18. 2 One theoretical risk involves the phenomenon of antibody-mediated enhancement 
of infection (ADE). ADE can occur for several viral diseases and involves an enhancement 
of disease in the presence of certain antibodies. For coronaviruses, several mechanisms 
for ADE have been described and there is the theoretical concern that antibodies to one 
type of coronavirus could enhance infection to another viral strain (Casadevall, 2020). It 
may be possible to predict the risk of ADE of SARS-CoV-2 experimentally, as proposed 
for MERS. Since the proposed use of convalescent plasma in the COVID-19 epidemic 
would rely on preparations with high titers of neutralizing antibody against the same 
virus, SARS2-CoV-2, ADE may be unlikely. The available evidence from the use of 
convalescent plasma in patients with SARS1 and MERS and anecdotal evidence of its use 
in patients with COVID-19 (Casadevall 2020), suggest it is safe. Nevertheless, caution 
and vigilance will be required in for any evidence of enhanced infection. Both COVID-19 
and ADE may cause ARDS, and we recognize that this will be very difficult to attribute 
etiology in this small pilot study.  None-the-less, we will pay particular attention to the 
incidence of ARDS in study subjects without comorbidities predicting risk of progression 
to severe disease, and we will closely follow any reports suggesting ADE that emerge 
from multicenter, placebo-controlled trials of CP, including two proposed CTSC-based 
RCTs for outpatient PrEP and outpatient treatment of early COVID-19 with CP, and we 
will forward any reports suggesting ADE to the IRB.
18.2 Another theoretical risk is that antibody administration to those infected by SARS-
CoV-2 may avoid disease but modify the immune response such that those individuals 
mount attenuated immune responses, thereby leaving them vulnerable to subsequent 
re-infection. It will not be feasible to assess this risk in data collected in this hospital-
based treatment study, but we will monitor the emerging scientific literature and report 
any concerning findings to the IRB.
18.3 There are risks associated with any transfusion of plasma including transmission of 
transfusion transmitted viruses (e.g. HIV, HBV, HCV, etc.), allergic transfusion reactions, 
anaphylaxis to transfusion, febrile transfusion reaction, transfusion related acute lung 
injury (TRALI), transfusion associated cardiac overload (TACO), and hemolysis should 
ABO incompatible plasma be administered.  In order to minimize the risks of disease 
transmission, donors will fulfill donor requirements for blood donation with the 
exception of recent illness, in this case COVID-19 infection.
18.4 Venipuncture can cause bruising, bleeding and mild discomfort. It is infrequently 
associated with infection.  To minimize the risk of phlebotomy, only adequately trained 


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 18 of 30
Version: 1 Date: 5/04/2020
study personnel or hospital personnel will draw blood.  Blood volumes to be obtained 
fall within OHRP guidelines for minimal risk studies.  Alternative procedures are not 
feasible.
18.5 Breach of confidentiality from data obtained during the enrollment interview or 
clinical charts.  Subject confidentiality will be maintained by the following methods:  All 
records will be kept in a locked file.  All computer entry and networking will be 
performed with coded numbers only.  Clinical information will not be released without 
written permission from the subject.  Access to identified, source records will be limited 
to the local site principal investigator and study personnel.  
18.6. 1.1.1.     Mild to discomfort from obtaining NP.  Nasal swabs can be performed 
without discomfort or risk. To minimize discomfort from obtaining nasal or NP swabs, 
these will be obtained by trained medical personnel, and subjects who cannot tolerate 
NP swabs will only have nasal swabs obtained.
 
19. Potential Benefits to Subjects
A key potential benefit is treatment for established infection.  Convalescent plasma would be 
administered to those with clinical disease in an effort to reduce their symptoms and mortality. 
Based on the historical experience with antibody administration, it can be anticipated that 
antibody administration relatively early in the course of disease would be more effective in 
preventing disease progression than in the treatment of established severe disease.
Given that historical and current anecdotal data on use of convalescent plasma suggest it is safe 
in coronavirus infection, the high mortality of COVID-19, particularly in elderly and vulnerable 
persons, suggests that the benefits of its use in those at high risk for or with early disease 
outweigh the risks. However, for all cases where convalescent plasma administration is 
considered, a risk-benefit assessment must be conducted to assess individual variables.
20. Recruitment Methods
Members of the research team will review the list of admitted or hospitalized patients with
a positive SARSCoV-2 test. Alternatively, treating providers may also notify the research team of 
the admission of SARSCoV-2 patients or the positive result of a suspected COVID-19 patient.
21. Provisions to Protect the Privacy Interests of Subjects
21.1.
Only members of the research team will access trial related documents.
21.2.
All study procedures will be conducted in the participant’s room or other private 
area of the hospital.
22. Economic Burden to Subjects


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 19 of 30
Version: 1 Date: 5/04/2020
22.1.
The study is responsible for the cost of any research-related procedures. The 
participant and/or third party payer is responsible for any standard of care procedures. 
22.2.
Investigators do not anticipate any additional costs. 
23. Compensation
No compensation will be given to study participants.
24. Compensation for Research-Related Injury
 The University of New Mexico does not have funds set aside to pay for the cost of any care or 
treatment that might be necessary or for any wages lost as a result of participating in this study. 
Medical costs to care and treatment of study related harm will be billed to the participant 
and/or third party payer. 
25. Consent Process
25.1.
An approved member of the study team will conduct the consent process with 
the participant and/or their LAR in a private area of the hospital or by phone if needed. 
If applicable, impartial witness will be utilized as needed (witness/translator for Spanish 
speaking participant and impartial witness for phone consent). 
25.2.
It may not be possible to have an in-person discussion of the study with 
participants or their LAR. Documenting written informed consent in these instances 
must involve a process as follows: the participant or their LAR receives a copy of the 
informed consent document in advance of a telephone discussion. The investigator 
obtains consent over the telephone with the participant or their LAR. If LAR consented 
via phone, a copy of the consent will be mailed to LAR. 
25.3.
The informed consent form may be mailed, emailed or faxed to the participant 
or their LAR. The consent discussion may then be conducted by telephone or in person 
when the subject or subject’s LAR can read the consent form during the discussion.
25.4.
Investigators will explain the study to the potential participant or their LAR by 
reading the informed consent document to the participant and/or LAR, providing all 
pertinent information (purpose, procedures, risks, benefits, alternatives to 
participation), and allowing the potential participant or their LAR ample opportunity to 
ask questions. This can be done by phone or in person. 
25.5.
Investigators will ensure a thorough verbal discussion by phone or in person of 
the consent form. Investigators will allow the potential participant or LAR time to read 
the consent form and allow the participant or their LAR sufficient time to consider 
whether or not to participate in the research.


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 20 of 30
Version: 1 Date: 5/04/2020
25.6.
Investigators will ensure the potential participant or their LAR additional 
questions s/he may have are addressed. 
25.7.
Participants and/or their LAR will be asked to explain the purpose of the study, 
procedures involved, and/or conditions for participation to confirm understanding.
25.8.
If the participant or LAR agrees to participation, s/he signs the consent form and 
returns it to the investigator for signature and date. The signed and dated consent form 
can be returned to investigators by mail, facsimile, or by scanning the consent form and 
returning it through a secure e-mail account. 
25.9.
Once the signed form is received, the investigator who conducted the informed 
consent will sign and date the consent and will ensure the participant or their LAR 
receives a copy of the fully signed consent form. The fully signed original consent form 
will be filed with the participant’s study records.   
25.10.
Ongoing consent from participants and and/or their LAR will be ascertained as 
research procedures are being conducted.
25.11.
Alternately, on a case-by-by case basis, and per the FDA regulation 21
CFR 50.23 Exception from general requirements, the following will be done:
(a) The obtaining of informed consent shall be deemed feasible unless, before use
of the test article (except as provided in paragraph (b) of this section), both the
investigator and a physician who is not otherwise participating in the clinical
investigation certify in writing all of the following:
(1) The human subject is confronted by a life-threatening situation necessitating the use
of the test article.
(2) Informed consent cannot be obtained from the subject because of an inability
to communicate with, or obtain legally effective consent from, the subject.
(3) Time is not sufficient to obtain consent from the subject's legal representative.
(4) There is available no alternative method of approved or generally recognized therapy
that provides an equal or greater likelihood of saving the life of the subject.
(b) If immediate use of the test article is, in the investigator's opinion, required
to preserve the life of the subject, and time is not sufficient to obtain the independent


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 21 of 30
Version: 1 Date: 5/04/2020
determination required in paragraph (a) of this section in advance
of using the test article, the determinations of the clinical investigator shall be
made and, within 5 working days after the use of the article, be reviewed and
evaluated in writing by a physician who is not participating in the clinical
investigation.
(c) The documentation required in paragraph (a) or (b) of this section shall be
submitted to the HRRC as a Reportable New Information (RNI) within 5
working days after the use of the test article. The documentation to be used within the
RNI is titled “Informed Consent Exception from General Requirements”. The form can be 
             completed via eSignatures by utilizing the fillable form or hand written signatures by
utilizing the non-fillable form.
Subjects not fluent in English
25.12 Given the public health emergency surrounding this research, non-English 
speaking patients may be included in the study, and this will only include Spanish 
speaking individuals. 
25.13 The consent process will be conducted by a member of the study team fluent in 
the Spanish language and/or with the assistance of a qualified interpreter.
Cognitively Impaired Adults/Adults Unable to Consent/Use of a Legally Authorized 
Representative
25.14 Some participants are expected to be cognitively impaired, either due to a pre-
existing condition, or because of conditions related to their infection with COVID-19. 
Cognitively impaired participants will be enrolled in the study with the consent of their 
LAR
The study team, in consultation with the clinical care provider, will determine if a 
participant has capacity to consent. Specifically, the investigators will utilize the 
rCapacity to Consent Quiz or the GCP teach back technique with the consent form. After 
each section of consent form has been discussed with the participant, the investigator 
will ask the participant to explain their understanding of the content. Based on the 
results, the investigators will determine if the participant has the ability to consent. 
Capacity to consent will be evaluated by the study team, in consultation with the clinical 
care provider, as part of the ongoing consent process as described above. If the 
participant regains capacity to consent, a member of the study team will conduct the 
consent process as described above.


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 22 of 30
Version: 1 Date: 5/04/2020
We will obtain evidence of agency under a durable power of attorney or surrogate 
health decision maker status under the NM Uniform Health Care Decisions Act, NMSA 
1978, 24-7A-1 et seq.  
Subjects who are not yet adults (infants, children, teenagers)
N/A
Waiver or Alteration of Consent Process (consent will not be obtained, required element of 
consent will not be included, or one or more required elements of consent will be 
altered) 
Waivers of consent and HIPAA authorization are requested for screening/ recruitment 
purposes. For the waiver of HIPAA authorization, the Data Warehouse will generate a daily list 
of patients with documented positive COVID-19 with their locations in the hospital. The 
attending will be contacted via tigerconnect to consent and start the treatment. 
26. Documentation of Consent
26.1.
For English-speaking participants (or LARs), consent will be documented using an 
HRRC-approved consent document.
26.2.
For Spanish speaking participants (or LARs), a Short Form of Consent in their 
preferred language will be used to document consent.
27. Study Test Results/Incidental Findings
27.1. Individual Results: Results of the titers of neutralizing antibodies and nasopharyngeal 
SARSCoV-2 will be not be shared with the participants and their providers. The rest of 
routine laboratory and clinical notes will be available in the electronic medical record 
patient portal 
28. Sharing Study Progress or Results with Subjects
28.1. During the study we do not intend to provide subjects with a summary of the trial. 
This a short, pilot study and results will be compiled at the end and then results will be 
informed in writing to the patients at that moment.
29. Inclusion of Vulnerable Populations 
Cognitively impaired adults will be included in the study since the disease under 
investigation disproportionately affects older adults and/or contributes to the 
temporary cognitive impairment of a significant proportion of patients. To protect 
their rights and welfare, consent will be sought from competent ;iLAR, and 
participants who regain capacity to consent as (determined by the study team in 
consultation with clinical care providers) will be re-consented.
30. Community-Based Participatory Research N/A
31. Research Involving American Indian/Native Populations N/A
32. Transnational Research N/A


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment 
with investigational convalescent plasma and measure antibody levels in patients 
hospitalized with COVID-19 
Page 23 of 30
Version: 1 Date: 5/04/2020
33. Drugs or Devices:
See section 12.1
34. Principal Investigator’s Assurance
By submitting this study in the Click IRB system, the principal investigator of this study confirms 
that:
☐ X The information supplied in this form and attachments are complete and correct.  
☐ X The PI has read the Investigator’s Manual and will conduct this research in accordance with 
these requirements. 
 ☐ X Data will be collected, maintained and archived or destroyed per HSC Data Security Best 
Practices, including:
1. Best Practice for data collection is for it to be directly entered onto a data collection 
form that is in a secured access folder on an HS drive behind a firewall, or in a secure 
UNM Data Security approved system such as RedCap.
2. Data collection of de-identified data, if done in a clinical setting or other setting that 
does not allow direct entry into a secured system, may be done temporarily using a 
personal or university owned electronic storage device or hard copy document. The 
important security safeguard is that no identifiers be included if the data is entered or 
stored using an untrusted device or storage.
3. Permanent (during data analysis, after study closure) storage must reside on HSC 
central IT managed storage. Processing of data (aggregation, etc.) are to be carried out 
in such a way as to avoid creating/retaining files on untrusted storage 
devices/computers. Trusted devices are HSC managed and provide one or more of the 
following safeguards: access logs, encryption keys, backups, business continuity and 
disaster recovery capabilities.
4. Alternate storage media must be approved by HSC IT Security as meeting or exceeding 
HSC central IT provided security safeguards.


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment with 
investigational convalescent plasma and measure antibody levels in patients hospitalized with 
COVID-19 
Page 24 of 30
Version: 1 Date: 5/04/2020
35. CHECKLIST SECTION
This section contains checklists to provide information on a variety of topics that require special 
determinations by the IRB.  Please complete all checklists relevant to your research.
36. Partial Waiver of Consent for Screening/Recruitment
Complete this checklist if you are requesting a partial waiver of consent so that you can review 
private information to identify potential subjects and/or determine eligibility prior to 
approaching potential subjects for consent or parental permission.
A. Describe the data source that you need to review (e.g., medical records):
Medical Record
B. Describe the purpose for the review (e.g., screening):
Screening and Recruitment
C. Describe who will conducting the reviews (e.g., investigators, research staff):
Principal Investigator with other members of the study team
D. Do all persons who will be conducting the reviews already have permitted access to the 
data source?
      ☒ Yes
            ☐ No. Explain:      
i. Verify that each of the following are true or provide an alternate 
justification for the underlined regulatory criteria:
1. The activity involves no more than minimal risk to the subjects 
because the records review itself is non-invasive and the results of 
the records review will not be used for any purposes other than those 
described above.
☐ True
☐ Other justification:      
2. The waiver or alteration will not adversely affect the rights and 
welfare of the subjects because eligible subjects will be approached 
for consent to participate in the research and are free to decline.  
Further, the information accessed during the records review will not 
be disclosed to anyone without a legitimate purpose (e.g., verification 
of eligibility).


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment with 
investigational convalescent plasma and measure antibody levels in patients hospitalized with 
COVID-19 
Page 25 of 30
Version: 1 Date: 5/04/2020
☐ True
☐ Other justification:      
3. The research could not practicably be carried out without the waiver 
or alteration because there is no other reasonably efficient and 
effective way to identify who to approach for possible participation in 
the research.  
☐ True
☐ Other justification:      
4. Whenever appropriate, potentially eligible subjects will be presented 
with information about the research and asked to consider 
participation.  (Regulatory criteria: Whenever appropriate, the 
subjects will be provided with additional pertinent information after 
participation.)
☐ True
☐ Other justification:      
37.  Partial Waiver of HIPAA Authorization for Screening/Recruitment
Complete the following additional questions/attestations if the records you will review to 
identify potential subjects and/or determine eligibility include Protected Health Information 
(PHI).
A. Will you be recording any PHI when conducting the records review to identify potential 
subjects and/or determine eligibility?
            ☐ Yes. Describe:      
            ☒ No
B. If you answered “Yes” to question 6 above, please describe when you will destroy 
identifiers (must be the earliest opportunity consistent with the conduct of the 
research) or provide justification for why they must be retained:
     
C. The PHI accessed or recorded for identification/screening purposes will not be reused or 
disclosed to (shared with) any other person or entity, except as required by law, for 
authorized oversight of the research study, or for other research for which the use or 
disclosure of the PHI would be permitted under the Privacy Rule.
      ☒ True


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment with 
investigational convalescent plasma and measure antibody levels in patients hospitalized with 
COVID-19 
Page 26 of 30
Version: 1 Date: 5/04/2020
            ☐ False
38. Waiver of Documentation of Consent N/A
39. Alteration of Consent N/A
40. Full Waiver of Consent/Parental Permission N/A
41. Full Waiver of Consent/Parental Permission (Public Benefit or Service Programs) : N/A
42. Full Waiver of HIPAA Authorization (Checklist) N/A
43. Other Waiver Types (Checklist):N/A
44. Vulnerable Populations (Checklist)
A. Adults with Cognitive Impairments
Complete this checklist if the subject population will include adults with cognitive 
impairments.  
This checklist does not need to be completed if the research doesn’t involve 
interactions or interventions with subjects and will be conducted under a waiver of 
consent.
1. Describe why the objectives of the study cannot be met without inclusion of 
adults with cognitive impairments.
COVID-19 infection may affect persons with pre-existing cognitive impairment 
for whom no SOC treatment exists. COVID-19 infection can cause conditions 
resulting in cognitive impairment. 
2. Describe how capacity to consent will be evaluated.
By the research team in consultation with clinical care provider, by capacity 
to consent quiz or by the teach back technique.
3. If subjects may regain capacity to consent, or if subjects may have fluctuating 
capacity to consent, describe your plans to evaluate capacity to consent 
throughout the research and to obtain consent to continue participation if 
capacity is regained.
Capacity to consent will be assessed as part of the ongoing consent process. 
To protect their rights and welfare, consent will be sought from competent 
LAR, and participants who regain capacity to consent as (determined by the 
study team in consultation with clinical care providers) will be re-consented.


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment with 
investigational convalescent plasma and measure antibody levels in patients hospitalized with 
COVID-19 
Page 27 of 30
Version: 1 Date: 5/04/2020
4. Describe your plans, if any, to provide information about the research to 
subjects and the steps you will take to assess understanding.
The investigators will utilize the Capacity to Consent Quiz with the consent 
form. After the consent form has been discussed with the participant, the 
investigator will administer the Capacity to Consent Quiz or by teach back 
technique after each section of the consent. Based on the results, the 
investigators will determine if the participant or LAR has the ability to 
consent.
5. Describe your plans to obtain assent, including whether assent will be 
obtained from none, some, or all subjects.
6. Describe why risks to subjects are reasonable in relation to anticipated 
benefits to the subjects.
There is no SOC treatment for COVID-19 infection
7. If this study involves a health or behavioral intervention, describe why the 
relation of the anticipated benefit to the risk of the research is at least as 
favorable to the subjects as that presented by alternative procedures.
There is no SOC treatment for COVID-19 infection
8. Describe your plans for monitoring the well-being of subjects including any 
plans to withdraw subjects from the research if they appear to be unduly 
distressed.
All COVID-19 patients enrolled in this study will be hospitalized and closely 
monitored. Treating providers and members of the research team will be 
attentive to the clinical condition of all subjects.
B. Children N/A
C. Pregnant Women and Fetuses N/A
D. Neonates of Uncertain Viability or Nonviable Neonates N/A
E. Nonviable Neonates N/A
F. Biomedical and Behavioral Research Involving Prisoners N/A
45. Medical Devices (Checklist) N/A
 
46. Export Control (Checklist) N/A
47. Data Transfer/Sharing (Checklist)


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment with 
investigational convalescent plasma and measure antibody levels in patients hospitalized with 
COVID-19 
Page 28 of 30
Version: 1 Date: 5/04/2020
Complete this checklist if the research involves transferring/sharing of data with an external 
entity (institution, company, etc.). 
A. Will data be transferred/shared with an external entity (institution, company, etc.)?  
☐ Yes
☒ No. The remainder of this section does not apply. 
B. Indicate if the data is incoming and/or outgoing:        
C. Provide the name of the entity that data will be transferred/shared with:      
D. Provide the contact name, email and phone number with whom data is being             
transferred/shared with:      
E. Who is responsible for transmission of the data?           
F. Who is responsible for receiving the data?      
G. Describe how the data will be transferred/shared. Please note data cannot be 
transferred/shared without assistance from UNM HSC IT. Requesting HSC Central IT 
Transfer is detailed on the Sponsored Projects website:           
H. For data being transferred/shared with outside locations or entities, describe the 
following:
●
Where is data storage and how will it be maintained in a secure manner (i.e. 
encryption, password protection, use of Qualtrics or REDCap, etc)?      
●
What is method in which data will be collected and stored (i.e. electronic, hard 
copy, etc)?           
●
How long will the data be stored?           
●
Who will have access to data?        
I.
 Please list all specific data elements, variables, etc. to be sent out and/or received. 
Indicate if the data contains identifiers and health information. Please note that 
identifiers that MUST be removed to make health information de-identified are as 
follows: Names, All geographic subdivision smaller than a State, All elements of year 
(except year), Telephone, Fax numbers, E-mail addresses, Social Security, Medical 
record number, Health plan beneficiary, Account numbers, Certificate/license numbers, 
Vehicle identifiers and serial numbers, Device identifiers and serial numbers, Web URLs, 
IP address numbers, Biometric identifiers, full face photographic images, and Any other 
unique identifying number, characteristic or code.)           
J.
If the research requires the access, use, or disclosure of any of the 18 individually 
identifiable protected health information (PHI) identifiers that can be used to identify, 
contact, or locate a person (e.g., name, medical record number, etc.), are the subjects 
going to consent to or authorize the disclosure of their individually identifiable health 
information?       
a. Or is HIPAA authorization altered or waived?          
K. What is the classification of the data (de-identified, limited data set, protected health 
information, other).      


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment with 
investigational convalescent plasma and measure antibody levels in patients hospitalized with 
COVID-19 
Page 29 of 30
Version: 1 Date: 5/04/2020
L.
Does the request to transfer/share data include clinical data that belongs to the UNM 
Health Systems?      
M. Does the data to be transferred/shared include information about patients seen at 
external health systems or at a third party medical provider?      
N. Is the external entity a “covered entity”?        
O. Is the data that is going to be transferred/shared owned or partially owned by another 
party or have any type of restrictions including regulatory restrictions (i.e. HIPAA, 
FERPA, etc.)?      
P. Is the data publically available? If yes, please provide details:      
Q. Does the data include information about substance abuse treatment, sexually 
transmitted diseases, genetic testing results, HIV/AIDS testing results, and/or mental 
health?         
48. Specimen Transfer/Sharing (Checklist)
Complete this checklist if the research involves transferring/sharing of specimens with an 
external entity (institution, company, etc.). 
A. Will specimens be transferred/shared with an external entity (institution, company, 
etc.)? 
          Yes
X No. The remainder of this section does not apply. 
B. Indicate if the specimens are incoming and/or outgoing: 
C. Provide the name of the entity that specimens will be being transferred/shared with: 
D. Provide the contact name, email and phone number with whom specimens are being 
transferred/shared with: 
E. Who is responsible for sending out the specimens? Please note specimens cannot be 
sent out without a fully executed material transfer agreement. Michelle Harkins
F. Who is responsible for receipt of the specimens? Please note specimens cannot be 
received without a fully executed material transfer agreement. 
G. For specimens being transferred/shared with outside locations or entities, describe the 
following:
●
Where is specimen storage and how will it be maintained in a secure manner?      
●
What is the method in which specimens will be collected and stored? Collected: 
phlebotomy and stored: 
●
How long will the specimens be stored? 
●
Who will have access to the specimens


PROTOCOL TITLE: Open, non-comparative pilot study to provide access to treatment with 
investigational convalescent plasma and measure antibody levels in patients hospitalized with 
COVID-19 
Page 30 of 30
Version: 1 Date: 5/04/2020
49. References
 
Casadevall A, Pirofski L. The Convalescent Sera Option for COVID-19. J Clin Invest. 
https://doi.org/10.1172/JCI138003. 
Cheng Y, Wong R, Soo Y, Wong W, Lee C, Ng M, et al. Use of convalescent plasma therapy in 
SARS patients in Hong Kong. European Journal of Clinical Microbiology and Infectious Diseases. 
2005;24(1):44–46.
Yeh K-M, Chiueh T-S, Siu L, Lin J-C, Chan PK, Peng M-Y, et al. Experience of using convalescent 
plasma for severe acute respiratory syndrome among healthcare workers in a Taiwan hospital. 
Journal of Antimicrobial Chemotherapy. 2005;56(5):919–922. 
(Shen C, Wang Z, Zhao F, Yang Y, Li J, Yuan J, et al. Treatment of 5 Critically Ill Patients with 
COVID-19 with Convalescent Plasma. JAMA. doi:10.1001/jama.2020.4783 Published online 
March 27, 2020
Duan K, Liu B., Li Cesheng, Zhuang H, Yu T, Qu J, et al. The feasibility of Convalescent Plasma 
Therapy in Severe COVID-19 patients: a pilot study medRxiv preprint doi: 
https://doi.org/10.1101/2020.03.16.20036145.
Vial PA, Valdivieso F, Calvo M, et al. A non-randomized multicentre trial of human immune 
plasma for treatment of hantavirus cardiopulmonary syndrome caused by Andes virus. Antivir 
Ther. 2015;20:377-86. PMID: 25316807.
Mair-Jenkins J, Saavedra-Campos M, Baillie JK, et al.The effectiveness of convalescent plasma and 
hyperimmune immunoglobulin for the treatment of severe acute respiratory infections of viral 
etiology: a systematic review and exploratory meta-analysis. The Journal of infectious diseases. 
2015; 211(1):80-90

ICF_000.pdf: 
Page 1 of 8
Consent v1.0 4-29-2020
                                     The University of New Mexico Health Sciences Center
Consent and Authorization to Participate in a Research Study
Key Information for Open, non-comparative pilot study to provide access to treatment with 
investigational convalescent plasma and measure antibody levels in patients hospitalized with 
COVID-19 
You are being invited to take part in a research study about a proposed treatment of COVID-19 with 
plasma collected from people who have had COVID-19 and have recovered.
WHAT IS THE PURPOSE, PROCEDURES, AND DURATION OF THE STUDY?
The purpose of this research is to provide access to treatment with investigational convalescent plasma in 
patients hospitalized with COVID-19 and to learn if treatment boosts your antibody levels. “Convalescent 
plasma”, or CP, refers to the liquid part of blood taken from people who have recovered from COVID-19 
infection. CP does not contain blood cells but it does contain antibodies to SARS-CoV-2, the virus that 
causes COVID-19. Antibodies are part of your immune system, and it is thought that these antibodies 
may help fight SARS-COV-2 infection. You may be eligible for treatment with CP if you are currently 
hospitalized with a confirmed positive test for COVID-19 virus.  Your participation in this research may 
include blood tests for pregnancy and blood type and a nasal swab test for COVID-19 if these have not 
already been done.  If you are eligible, you will receive one unit (200 ml or about seven ounces) of CP, 
and you’ll have blood drawn for routine laboratory tests and virus antibody levels. Additional swabs will 
be taken from the front or back of your nose to monitor changes in the virus on the day of the transfusion 
and days 1, 3, 7, and 14. Your participation in this research will end when you leave the hospital.  
WHAT ARE THE KEY REASONS YOU MIGHT CHOOSE TO VOLUNTEER FOR THIS 
STUDY?
It is possible that you may benefit from plasma transfusion if the antibodies in the plasma help fight  
SARS-CoV-2 infection.  For a complete description of benefits, refer to the Detailed Consent. 
WHAT ARE THE KEY REASONS YOU MIGHT NOT CHOOSE TO VOLUNTEER FOR THIS 
STUDY?
Convalescent plasma treatment is investigational and has not been proven to benefit COVID-19 patients. 
You may choose not to participate because plasma transfusion is accompanied by a risk, and it may not 
help you fight the virus.  For a complete description of risks and alternate treatment/procedures, refer to 
the Detailed Consent.
DO YOU HAVE TO TAKE PART IN THE STUDY?
If you decide to take part in the study, it should be because you really want to volunteer. You will not lose 
any services, benefits or rights you would normally have if you choose not to volunteer.
WHAT IF YOU HAVE QUESTIONS, SUGGESTIONS OR CONCERNS?
The person in charge of this study is Dr. Michelle Harkins of the University of New Mexico Health 
Sciences Center, Department of Internal Medicine. If you have questions, suggestions, or concerns 
regarding this study or you want to withdraw from the study, her contact information is 
mharkins@salud.unm.edu or 505-272-4751.


Page 2 of 8
Consent v1.0 4-29-2020
If you have any questions or concerns about your rights as a volunteer in this research, contact staff in the 
University of New Mexico Health Sciences (UNMHSC) Human Research Review Committee (HRRC) 
between the business hours of 8AM and 5PM, Mountain Pacific Time (MPT), Monday-Friday at 505-
272-1129. 


Page 3 of 8
Consent v1.0 4-29-2020
DETAILED CONSENT
Version 1.0 April 29, 2020
ARE THERE REASONS WHY YOU WOULD NOT QUALIFY FOR THIS STUDY? 
The reasons you would not qualify for this study include being under 18 years of age, having a negative 
test for SARS-CoV-2 from nose swabs, inability for you or your legally authorized representative to 
provide consent, if you are female and are pregnant or breastfeeding, or you have a history of severe 
allergic reactions to blood or plasma infusions. 
WHERE IS THE STUDY GOING TO TAKE PLACE AND HOW LONG WILL IT LAST?
The research procedures will be conducted at UNMH. You will be evaluated up to six times during the 
study. Each of those visits will take 10-20 minutes, and the plasma infusion will take no more than four 
hours. The total amount of time you will be asked to volunteer for this study is about five hours during 
your hospitalization.  
WHAT WILL YOU BE ASKED TO DO?
If you agree to participate, you will be asked about your symptoms, travel history, exposure to persons 
with COVID-19,  medications before entering the hospital and your medical records and laboratory 
results will be reviewed in the electronic medical record in the hospital.  If you do not have a positive test 
for COVID-19 at the time of screening, your nose or throat will be swabbed. If you are a female who 
could become pregnant, you will be given a pregnancy test. Once we have confirmed that you are eligible 
for the study, you will receive a 200 ml (about seven ounces) infusion of plasma that was collected from 
someone who has recovered from COVID-19. 
Your blood pressure, pulse, breathing, and temperature will be checked just before, 10-20 minutes after 
starting the infusion, at the end of the infusion, and 30-60 minutes after the infusion.  Before the infusion, 
and 1, 3, 7, and 14 days after the infusion (if you are still in the hospital), one tube of blood (5-7 ml or one 
to one and a half teaspoons) of blood will be drawn and your nose or throat will be swabbed. If you can’t 
tolerate swabs to the back of the nose, only the front of your nose will be swabbed.  You will also be 
asked about symptoms and be examined on each of these days.  Treatment with plasma from persons who 
have recovered from COVID-19 is experimental, and everyone who participates in this research will 
receive this treatment. 
WHAT ARE THE POSSIBLE RISKS AND DISCOMFORTS?
Certain risks are associated with any transfusion of blood or plasma. It is possible that you might 
experience an allergic reaction to the plasma infusion that could include hives, itching and fever or even 
anaphylaxis, which is a severe, immediate and potentially life-threatening allergic reaction. Medical 
treatment will be provided to you in the event of an allergic reaction. Although is it uncommon, it is also 
possible for transmission of viruses (such as HIV, hepatitis B, hepatitis C and others) to occur through a 
plasma infusion. In order to minimize the risks of disease transmission, the person who donated the 
plasma you will receive will have fulfilled requirements for blood donation, and the plasma you receive 
will have been donated by a single, volunteer plasma donor. Other uncommon adverse reactions may 
include lung injury, overload of the heart, and hemolysis (breakage of blood cells). In event that these or 
any other adverse event occurs, you will receive medical treatment for them.


Page 4 of 8
Consent v1.0 4-29-2020
 
There is a risk that this experimental treatment could make your COVID-19 get worse, although this has 
not been observed in those who have already received this treatment.  It is also possible that this treatment 
could improve your condition now but not protect you against getting COVID-19 again in the future.
There is always a chance that any medical treatment can harm you. The research treatments/procedures in 
this study are no different. In addition to risks described in this consent, you may experience a previously 
unknown risk or side effect.
The drawing of blood with a needle from an arm vein usually causes mild pain (90%) and rarely causes a 
bruise (1%).  There is a remote chance of fainting (less than 0.1%) and a very remote chance of infection 
(less than 0.01%).  
There is a slight possibility that you may experience a loss of confidentiality regarding your medical records 
if you are enrolled in this study. In order to protect the privacy of your clinical information, the research 
team will take measures like restricting access to your records and using security passwords and locked 
cabinets for storing the data. 
WILL YOU BENEFIT FROM TAKING PART IN THIS STUDY? 
We do not know if you will get any benefit from participating in this study.  You may or may not benefit 
from this treatment, but we are studying it because be believe it may help improve your condition. And, if 
you take part in this study, information learned may help others with your condition.
WHAT WILL IT COST YOU TO PARTICIPATE?
There are no costs associated with taking part in the study.
You and/or your insurance company, Medicare, or Medicaid will be responsible for the costs of all care 
and treatment that you would normally receive for any conditions you may have. These are costs that are 
considered medically necessary and will be part of the care you receive even if you do not take part in this 
study.
The University of New Mexico may not be allowed to bill your insurance company, Medicare, or 
Medicaid for the medical procedures done strictly for research.
WHO WILL SEE THE INFORMATION THAT YOU GIVE?
When we write about or share the results from the study, we will write about the combined information of 
everyone who participated in the study. We will keep your name and other identifying information 
private. 
We will make every effort to prevent anyone who is not on the research team from knowing that you gave 
information, or what the information is. 


Page 5 of 8
Consent v1.0 4-29-2020
You should know there are some circumstances in which we may have to show your information to other 
people. For example, the law may require us to share your information with the following agencies and 
for the following reasons: 

The law requires us to share your information with authorities if you report information about a 
child being abused

If you pose a danger to yourself or someone else. 

A court or agencies, if you have a reportable disease or condition.

Authorities, if you report information about a child being abused, if you pose a danger to yourself 
or someone else. 
Deidentified information (without your name or other identifiers) with data collected from you in the 
research study will be stored in REDCap. REDCap is a secure, web-based program to capture and store 
data at the University of New Mexico. Please be aware, while we make every effort to safeguard your 
data once received on servers via REDCap, that as with anything involving the internet, we can never 
guarantee the confidentiality of the data while still in route to the server. 
CAN YOU CHOOSE TO WITHDRAW FROM THE STUDY EARLY?
You can choose to leave the study at any time. You will not be treated differently if you decide to stop 
taking part in the study. 
If you choose to leave the study early, data collected until that point will remain in the study database and 
may not be removed.
The investigators conducting the study may need to remove you from the study. The study intervention, 
medication, and/or device will no longer be provided to you and may not be available for purchase. This 
may occur for a number of reasons. You may be removed from the study if you are not able to follow the 
direction or they find that your participation in the study is more risk than benefit to you.
You may be removed from the study if:

You are not able to follow the directions.

The investigators find that your participation in the study is more risk than benefit to you.
ARE YOU PARTICIPATING, OR CAN YOU PARTICIPATE, IN ANOTHER RESEACH 
STUDY AT THE SAME TIME AS PARTICIPATING IN THIS ONE? 
You may take part in this study if you are currently involved in another research study. It is important to 
let the investigator and your doctor know if you are in another research study, but involvement in this 
research will not prevent you from participation in other research studies unless prior convalescent plasma 
administration is not allowed by the other study. 
WHAT HAPPENS IF YOU GET HURT OR SICK DURING THE STUDY? 
If you believe you are hurt or if you get sick because of something that is due to the study, you should call 
Dr. Michelle Harkins at 505-272-4751 immediately. Dr. Harkins will determine what type of treatment, if 
any, is best for you at that time. 
It is important for you to understand that the University of New Mexico does not have funds set aside to 
pay for the cost of any care or treatment that might be necessary because you get hurt or sick while taking 


Page 6 of 8
Consent v1.0 4-29-2020
part in this study. Also, the University of New Mexico will not pay for any wages you may lose if you are 
harmed by this study.
WILL I BE PAID FOR PARTICIPATING IN THIS STUDY?
You will not receive any rewards or payment for taking part in the study. 
WHAT IF NEW INFORMATION IS LEARNED DURING THE STUDY THAT MIGHT AFFECT 
YOUR DECISION TO PARTICIPATE?
You will be informed if the investigators learn new information that could change your mind about 
staying in the study. You may be asked to sign a new informed consent form if the information is 
provided to you after you have joined the study.
WILL YOU BE GIVEN INDIVIDUAL RESULTS FROM THE RESARCH TESTS?
Tests for research purposes are not meant to provide clinical information/diagnoses and cannot be used 
to make decisions about standard medical care. 
The sample and/or information that you are donating will no longer belong to you. The research may 
lead to new medical knowledge, tests, treatments, or products. These products could have some 
financial value. There are no plans to provide financial payment to you or your relatives should this 
occur.
A description of this clinical trial will be available on ClinicalTrials.gov as required by U.S. Law. This 
website will not include information that can identify you. At most, the website will include a summary of 
the results. You can search this website at any time. 
WHAT ELSE DO YOU NEED TO KNOW?
If you volunteer to take part in this study, you will be one of 30 people to do so. 
PROTECTED HEALTH INFORMATION OR SPECIMEN(S). 
By signing this Consent Document, as described in this consent form, you are allowing the investigators 
and other authorized personnel to use your protected health information for the purposes of this study.  
This information includes results of physical examinations, medical history, and results of blood tests, 
including antibody results. 
In addition to researchers and staff at UNMHS and other groups listed in this form, there is a chance that 
your health information may be shared (re-disclosed) outside of the research study and no longer be 
protected by federal privacy laws.  Examples of this include health oversight activities and public health 
measures, safety, monitors, other sites in the study, companies that sponsor this study, government 
agencies such as Food and Drug Administration (FDA). 
Right to Withdraw Your Authorization
Your authorization for the use and disclosure of your health information for this study shall not expire 
unless you cancel this authorization.  This is because the information used and created during the study 
may be analyzed for many years and it is not possible to know when this will be complete. Your health 
information will be used or disclosed as long as it is needed for this study.  However, you may withdraw 


Page 7 of 8
Consent v1.0 4-29-2020
your authorization at any time provided you notify the UNM investigators in writing.  To do this, please 
send letter notifying them of your withdrawal to:
Michelle Harkins, MD 
MSC10 5550
1 University of New Mexico
Albuquerque New Mexico 87131
Please be aware that the research team will not be required to destroy or retrieve any of your health 
information that has already been used or shared before the date that your withdrawal is received.
If you become pregnant anytime during the study, you must inform the study doctor. The study doctor 
must then report the outcome of your pregnancy to the FDA). 
The researchers agree to only share your health information with the people listed in this document. 
Should your health information be released to anyone that is not regulated by the privacy law, your health 
information may be shared with others without your permission; however, the use of your health 
information would still be regulated by applicable federal and state laws. 
You may not be allowed to participate in the research study if you do not sign this form. If you decide not 
to sign this form it will not affect your: 

Current or future healthcare at the University of New Mexico;

Current or future payments to the University of New Mexico;

Ability to enroll in any health plans (if applicable); or

Eligibility for benefits (if applicable).
After signing the form, you can change your mind and NOT let the researcher(s) collect or release 
your health information (revoke the Authorization). If you revoke the authorization:

You will send a written letter to Dr Harkins to inform her of your decision. 

Researchers may use and release your health information already collected for his research study. 

Your protected health information may still be used and released should you have a bad reaction 
(adverse event). 
The use and sharing of your information has no time limit. 
If you have not already received a copy of the Privacy Notice, you may request one. If you have any 
questions about your privacy rights, you should contact the University of New Mexico Health Sciences 
Privacy Officer between the business hours of 8am and 5pm Mountain Pacific Time, Monday-Friday at 
(505) 272-1493.


Page 8 of 8
Consent v1.0 4-29-2020
INFORMED CONSENT SIGNATURE PAGE
You are participating or are authorized to act on behalf of the participant. This consent includes the 
following: 

Key Information Page

Detailed Consent
You will receive a copy of this consent form after it has been signed. 
Signature of research subject, or if applicable, 
Date
*research subject’s legal representative who may provide consent by phone
Printed name of research subject  
*If applicable, printed name of research subject’s legal representative: ___________________________ 
*If applicable, please explain Representative’s relationship to subject and include a description of 
representative’s authority to act on behalf of subject: 
____________________________________
I have witnessed the informed consent process. This informed consent form was verbally reviewed with 
the subject in addition to the HRRC approved short consent form and will act as the written summary of 
the discussion.
Witness (translator) printed name 
Witness (translator) signature and date 
I have witnessed the informed consent process that was conducted by phone call or by conference phone 
call. This informed consent form was verbally reviewed with the subject or their LAR.
_______________________________________     ___________________________________________
Impartial Witness to phone consent printed name    Impartial Witness to phone consent signature and date
Printed name of [authorized] person obtaining 
Date
informed consent/HIPAA Authorization
Signature of [authorized] person obtaining informed consent/HIPAA Authorization