Effects of Higher Dose and Lower Dose of Dexamethasone for Hospitalized Patients With COVID-19
Phase: PHASE4
Conditions: Covid19
Sponsor: University of Oklahoma

 
 
Effect of Higher vs. Lower Doses of Dexamethasone for COVID-19 
 
Clinialtrials.gov number, NCT04707534 
 
1/15/2021 

IRB NUMBER: 12927
IRB APPROVAL DATE: 01/15/2021
 PI Huimin Wu, Version # 1.0
  
IRB version 03/12/2019
1
Title of Project: Effect of higher vs. lower doses of dexamethasone for COVID-19
Principal Investigator:
Huimin Wu, MD MPH, Dept of Medicine
Co-Investigators: 
Brent Brown, MD; Fawad Chaudry; Salim Daouk, MD; Jad 
Kebbe, MD
Abstract
The coronavirus disease 2019 (COVID-19) pandemic is a serious global health 
threat. Multiple antiviral or immunomodulatory therapies have failed to show any 
mortality benefit for patients with COVID-19. Dexamethasone was shown in a 
large clinical trial to improve mortality. However, it is unclear what dose of 
dexamethasone is most beneficial in hospitalized patients with COVID-19. We 
plan to conduct a randomized single center open label clinical trial to evaluate two 
different doses of dexamethasone (20mg vs. 6mg) on the health outcome for 
hospitalized patients with COVID-19. The intervention arm is dexamethasone 
20mg daily for 5 days, followed by dexamethasone 10mg daily for 5 days. The 
comparator is dexamethasone 6mg daily for 10 days. Three hundred participants 
will be enrolled. The primary outcome is clinical improvement using World 
Health Organization ordinal scale at day 28 or live discharge, whichever comes 
first. Our hypothesis is that patients who are treated with dexamethasone 20mg 
daily are more likely to have clinical improvement compare to those who are 
treated with dexamethasone 6mg daily on day 28.
A.
Specific Aims
Studies showed dexamethasone has the mortality benefit and increases in the 
number of ventilator-free days for patients with COVID-19. However, there is no 
published trial to compare the health outcome for COVID-19 patients who are 
treated with different doses of dexamethasone. The primary aim of this study is to 
test the effectiveness of two difference dexamethasone dose to treat COVID-19. 
The hypothesis is that dexamethasone 20mg daily treatment is superior over 
dexamethasone 6mg daily in clinical improvement at day 28 using WHO ordinal 
scale for clinical improvement (1, 2)
B.
Background and Significance
As of December 2020, COVID-19 - caused by severe acute respiratory syndrome 
coronavirus 2 (SARS-CoV-2) - has infected more than 20 million people with 
more than 350,000 deaths in the United States. (3) Several pharmacologic 
therapies for use in patients with COVID-19 have been investigated in 
randomized trials. Most antiviral or immunomodulatory therapies investigated 
have failed to show any mortality benefit. Only dexamethasone showed to 
improve mortality in RECOVERY trial. (4) In this randomized, controlled, open-
label trial, dexamethasone 6 mg once daily (intravenous or by mouth) for up to 10 
days reduced 28-day mortality in hospitalized patients with COVID-19. Another 
multicenter trial (CoDEX) using dexamethasone 20mg daily for 5 days, followed 

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by 10mg daily for 5 days revealed dexamethasone increase in the number of 
ventilator-free days.(5) However, there is no published trial to evaluate the 
difference of health outcomes using different dose of dexamethasone. Currently 
OUHSC COVID-19 Task Force recommends dexamethasone 6mg daily for 10 
days for all hospitalized COVID-19 patients regardless of the respiratory status. 
(6) However, the COVID-19 morbidity and mortality remain high despite the 
recommended therapy. We plan to conduct a single center open label randomized 
clinical trial to investigate the heath outcomes in hospitalized patients with 
COVID-19 treated with dexamethasone 20mg daily for 5 days, 10mg daily for 5 
days (high dose) vs. dexamethasone 6mg daily for 10 days (low dose).  
C.
Preliminary Studies/Progress Report  
In RECOVERY trial, 2104 patients were assigned to receive dexamethasone 6mg 
daily for 10 days and 4321 to receive usual care (no dexamethasone). (4) Overall, 
482 patients (22.9%) in the dexamethasone group and 1110 patients (25.7%) in 
the usual care group died within 28 days after randomization (age-adjusted rate 
ratio, 0.83; 95% confidence interval [CI], 0.75 to 0.93; P<0.001). In the 
dexamethasone group, the incidence of death was lower than that in the usual care 
group among patients receiving invasive mechanical ventilation (29.3% vs. 
41.4%; rate ratio, 0.64; 95% CI, 0.51 to 0.81) and among those receiving oxygen 
without invasive mechanical ventilation (23.3% vs. 26.2%; rate ratio, 0.82; 95% 
CI, 0.72 to 0.94) but not among those who were receiving no respiratory support 
at randomization (17.8% vs. 14.0%; rate ratio, 1.19; 95% CI, 0.91 to 1.55). This 
trial concluded that in patients hospitalized with Covid-19, the use of 
dexamethasone resulted in lower 28-day mortality among those who were 
receiving either invasive mechanical ventilation or oxygen alone at randomization 
but not among those receiving no respiratory support.
In CoDex trial, 151 patients received 20mg of dexamethasone daily for 5 days, 
10mg of dexamethasone daily for 5 days or until ICU discharge and standard care, 
148 patients received standard care only.(5) Patients in the dexamethasone group 
had a mean 6.6 ventilator-free days (95% CI, 5.0-8.2) during the first 28 days vs 
4.0 ventilator-free days (95% CI, 2.9-5.4) in the standard care group (difference, 
2.26; 95% CI, 0.2-4.38; P = 0.04). Thirty-three patients (21.9%) in the 
dexamethasone group vs 43 (29.1%) in the standard care group experienced 
secondary infections, 47 (31.1%) vs 42 (28.3%) needed insulin for glucose 
control, and 5 (3.3%) vs 9 (6.1%) experienced other serious adverse events. It was 
concluded that among patients with COVID-19 and moderate or severe ARDS, 
use of intravenous dexamethasone plus standard care compared with standard care 
alone resulted in a statistically significant increase in the number of ventilator-free 
days (days alive and free of mechanical ventilation) over 28 days. 
D.
Research Design and Methods (What, When, How, Where)
1. Identify sources of research material in the form of biospecimens, records 
and/or data from interaction with participants.
The electronic medical records demographic and clinical data on participants 

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will be collected and analyzed.
2. Describe study design, including sequence and timing of study procedures. 
Distinguish research procedures from those that are routine care. Provide a 
flow diagram or timetable.

It is a single center open label randomized clinical trial to investigate 
the different dose of dexamethasone on the health outcomes in 
hospitalized moderate or severe COVID patients. 

It is a superiority trial. 

This trial has two parallel groups. The participants will be randomly 
assigned in a 1:1 ratio to intervention group and control group. 

We anticipate that approximately 300 participants will be enrolled and 
complete the study (Each group will enroll 150 participants.) The 
study plan to start as soon as the OUHSC IRB approves it and the 
duration is 28 days.

The COVID patients will be screened in the first 24 hours after 
investigators are contacted. 

Participants will be randomized to intervention arm or control arm 
after participants agree to be enrolled into the study and sign the 
informed consent. 

Except for the different doses of dexamethasone, participants will 
receive the routine medical care in OUMC. 
                                                                  Dexamethasone 20mg + Standard care    Outcome
Eligible individuals  Randomize                                      
                                                                  Dexamethasone 6mg + Standard care      Outcome
3. Include the study duration and number of study visits required.
This study will last for 5 months. There is only one visit for patients who are 
in OUMC for more than 28 days after randomization. There are two visits for 
patients who are not in OUMC at day 28 after randomization, first visit is the 
same as prior mentioned first visit, the second visit is a phone visit. The first 
visit is for screening, informed consent. After the visit, participants will be 
randomized and receive dexamethasone 20mg daily vs. 6mg daily. 
Participants will receive other routine medical care in the hospital till 
discharge. Research staff will review the hospital medical records daily to 
monitor the clinical improvement and any adverse event. At day 28, if 
participants are not in OUMC, research team will contact participants to 
evaluate the WHO ordinal scale.
4. Describe blinding, including justification for blinding or not blinding the trial.  
This is an open label trial. The study outcome is objective. Not blinding the 
trial does not affect the study outcome.
5. Include justification for inclusion of a placebo or non-treatment group.
This study does not include a placebo or non-treatment group. At least two 

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large clinical trials showed corticosteroids have benefit to COVID patients. 
Using placebo or non-treatment is not ethic. 
6. Describe what happens to participants receiving therapy when study ends or if 
their participation in the study ends prematurely.
Participation of the study ends after day 28. The investigator will not contact 
the participants or give other interventions or suggestions after day 28. 
Participants are welcome to contact the PI for any questions after study 
participation ends. 
7. Indicate where the procedures will be completed. 
a.
Include all sites where research activities will be conducted 
(consenting, interventions, chart reviews, data analysis, etc).
This research will be conducted in University of Oklahoma Health 
Sciences Center. Consenting and interventions will be conducted in 
University of Oklahoma Medical Center. Chart reviews and data 
analysis will be conducted in University of Oklahoma Medical Center 
and College of Medicine.
b.
Indicate that all required approvals are already obtained or will be 
obtained at each research location prior to project implementation.
This trial will be conducted at OUMC adult service. OUHSC IRB 
approval is needed. No other approval is needed. We will collaborate 
with other clinical services including emergency department and 
hospitalist service for participant recruitment. Dr. Brent Brown, study 
Co-PI and chief of pulmonary and critical care section will facilitate 
the collaborations. 
8. Indicate whether clinically relevant research results, including individual 
research results, will be disclosed to participants. If so, under what conditions? 
The individual research results, including the oxygen support information, the 
length of hospital stay, ICU care, ventilator use etc, will communicate with 
participants/guardians during routine patient care. The final deidentified data 
analysis results may be published in literatures.
9.  Identifiers might be removed and the de-identified information may be used 
for future research without additional informed consent from the subject.
E.
Chart Review
1.
List the data that will be used from the chart review. Alternatively, attach a 
separate data collection tool.
The chart review is prospective in nature. We will collect individuals’ basic 
characteristic and clinical variables, including date of birth, race/ethnicity, 
gender, insurance type, residential zip code, smoking history, height, weight, 
history of COVID vaccination, previous history of COVID, dexamethasone 
adverse events such as hyperglycemia, infections etc, respiratory support 
including nasal cannula oxygen, high flow oxygen, Bipap, mechanic 
ventilation, length of ICU stay, length of hospital stay, discharge disposition, 
health status 28 days after first dose of study dexamethasone eg. 
supplemental oxygen, tracheostomy, chronic mechanic support, daily activity 
limitation. We will also examine comorbidities including obesity, diabetes, 

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hypertension, hyperlipidemia, acute kidney injury, chronic kidney disease, 
heart failure, arrhythmia, coronary artery disease, psychological disease etc.
2.
Describe the databases that will be utilized, including specific sites from 
which you will collect data.
We will collect data from Meditech database in OUMC.
3.
Describe the process for obtaining and recording the records and at what 
point (if at all) the data is de-identified. 
The investigators conduct a review of records from their practice and 
collects medical records based on inclusion/exclusion criteria. Records 
will be de-identified during data analysis. 
4.
Explain how access to the data will be controlled and whether the access is 
logged. 
The electronic images of signed consent forms will be stored in a secured 
server in OUHSC campus. This secured server will be created with OUHSC 
IT service help. Only study team members have the access to the secured 
server. The data abstracted from Meditech will be store in REDCap. Only 
research team members have the access to REDCap.    
5.
What happens to the data at the end of the study?
The electronic data will be stored in the secured server and REDCap after the 
project closure for future research reference. 
F.
Biospecimens
No biospecimens will be collected.
G.
Banking/Repository/Database
Our Pulmonary Section of Department of Medicine plan to have long term 
research on respiratory failure due to COVID, including retrospective and 
prospective research. The data in this study will be important reference for 
future research. The electronic data will be stored in the same secured server 
in OUHSC. Only the study team members have the access to the data. PI 
will log into the server once per month to ensure the database function after 
the study is closed. PI will report to OUHSC IT for any concern regarding 
the database security. The data in REDCap will follow the regulation of 
OUHSC REDCap policy.
H.
Inclusion / Exclusion Criteria
1.
List the criteria that will define who will be included in the study
Age ≥ 18 years old

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PCR confirmed COVID-19 infection
Positive pressure ventilation (non-invasive or invasive) or high flow nasal 
cannula (HFNC) or need supplemental oxygen with oxygen mask or nasal 
cannula 
2.
List the criteria that will define who will be excluded in the study. 
Underlying disease requiring chronic corticosteroids
Severe adverse events before admission, i.e. cardiac arrest;
Contraindication for corticosteroids;
Death is deemed to be imminent and inevitable during the next 24 hours
Recruited in other clinical intervention trial
Pregnancy
Patient on judicial protection
3.
Provide early termination criteria.  
The study will be terminated early if COVID pandemic ends or there is no 
new COVID admission to OUMC or the interim data analysis (6 weeks after 
study start date) shows worse primary outcome in intervention group.
I.
Gender/Minority/Pediatric Inclusion for Research
Male and female adults will be included in the study. This study will be conducted in 
OUMC adult service. We will exclude participants age < 18 years old.
J.
Recruitment and Enrollment
1.
Describe the plans for recruitment.
a.
Methods to identify and recruit potential participants
The participants will be identified when the ICU service or the 
hospitalist service providers are contacted for admission. The 
providers will review all the clinical data and decide if the potential 
participants meet the inclusion criteria and contact the investigators.
b. If this is a multicenter study where subjects will be recruited by 
methods not under control of the local site (call centers, national 
advertisements), indicate this here.
This is not a multicenter study.
2.
Describe the consent procedures to be followed 
If the potential participant is able to consent him/herself (or at least assent), 
the potential participant will read and sign the consent form himself/herself. 
The paper consent form does not leave the patient room. Instead, the 
signature page is pressed up against the glass and the investigator takes a 
picture of the signature pages with his/her cell phone. 
If the potential participant is not able to consent/assent and consent is 
obtained from the power of attorney who is not physically present, consent is 

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obtained over the phone by the investigator with a witness listening. 
Informed Consent can be obtained verbally over the phone with a legally 
authorized representative and a witness, and the signed consent can be 
returned by fax, email or mail. The participant can be randomized and put in 
the study prior to return of the signed consent, however, if the signed consent 
is not returned, the participant will be removed from the study.
3.
Describe the location where consent is most likely to take place. 
The consent will be obtained while an inpatient (ICU, ER, and medial floor)
4.
Describe provisions for recruiting non-English speaking participants. 
The information on the informed consent form will be explained to patients 
or power of attorney and all questions will be answered using the hospital 
legal interpreter service before the consent form is signed. 
5.
Describe measures to decrease participant coercion 
The investigator allows the potential participant adequate time to review the 
consent, the investigator will answer all the questions the potential 
participant or power of attorney have before the consent form is signed.
K.
Risks and Benefits
The risks for participants who are on dexamethasone 20mg daily group may have higher 
risk of dexamethasone adverse effects such as infection, hyperglycemia etc.(7) The high 
dose dexamethasone has been used widely in clinical practice for many years and severe 
adverse effects are rare. The providers will monitor the adverse effects closely and start 
appropriate treatment such as antibiotics and insulin. If our study shows dexamethasone 
20mg daily therapy group has better health outcome, participants in this group will 
benefit from this therapy. On the other hand, the participants in dexamethasone 6mg daily 
group may not have the same good outcome as the dexamethasone 20mg daily group. 
Using dexamethasone 6mg daily may also cause hyper glycemia and infection etc 
requiring relevant treatment. 
The dexamethasone 20mg*5 days, then 10mg *5 days (10 days course) costs $11.85 
(vials) or $41.43 (tablets). The dexamethasone 6mg daily*10 days costs $59.1 (vials) or 
$131.9 (tablets). The cost of high dose therapy is lower than the low dose therapy. There 
should not be extra financial burden to the participants. 
 
Although one clinical trial found dexamethasone 6mg daily for 10 days had mortality 
benefit compared to usual care without dexamethasone therapy,(4) the difference of 
health outcome between high dose and low dose therapy is not confirmed. The mental 
risk to participant is minimal. The investigators will explain the study in details and 
answer all the questions to release the stress before participants/power of attorney decide 
to sign the consent. 

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The information which can be used to identify the participant including name, date of 
birth will be used only to locate the data in the database. The data will be de-identified 
during the data analysis process. The data will be stored in a secured server in OUHSC. 
Only the study team members have the access to the data. Patients’ personal information 
will not be released to public. There may not have direct benefit to the participants if our 
study does not reveal health outcome difference between the study groups, but the study 
results will help us to improve the COVID healthcare in general population.
 
L.
Multiple Sites
This study will be conducted in OUMC only.
M. Statistical Methods  
Dr. Huimin Wu, the PI and Dr. Salim Daouk, the co-investigator were trained in 
biostatistics and can guide and conduct the study design, sample size planning and 
statistical method. 
A sustained clinical improvement is defined as an improvement of > 2 points 
using ordinal scale (table 1). There is no direct ordinal scale data available on 
dexamethasone 6mg to treat COVID-19. According to the RECOVERY trial, (4) 
67.2% of patients in dexamethasone group were discharged from hospital within 
28 days, which means at least 67.2% of the patients have clinical improvement 
using ordinal scale. We estimate a 2-sided α level of 0.05 and power of 80% to 
detect a difference of improvement of 15% or 10% between groups, the sample 
size is calculated in table 2. Consider the patient census in OUMC, if we choose 
the 15% difference of improvement, we estimate 300 patients need to be 
enrolled.
Table 1. World Health Organization Ordinal Scale for Clinical Improvement (OSCI) 
scale for COVID-19
Descriptor
Score
Not hospitalized, no limitations on activities
1
Not hospitalized, limitation on activities
2
Hospitalized, not requiring supplemental oxygen
3
Hospitalized, requiring supplemental oxygen by mask or nasal prongs
4
Hospitalized, on non-invasive ventilation or high flow oxygen devices
5
Hospitalized, on invasive mechanical ventilation 
6
Hospitalized, on invasive mechanical ventilation + additional organ support 
(pressors, RRT, ECMO)
7
Death
8
Table 2. Sample size calculation
2-sided 
Dexamethasone 6mg Dexamethasone 20mg 
Sample 

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improvement%
improvement%
size
60
75
330
70
85
268
15% 
difference of 
improvement
80
95
176
60
70
752
70
80
626
α level 
of 0.05, 
power 
of 80%
10% 
difference of 
improvement
80
90
438
We will conduct descriptive statistics to characterize the study population at 
baseline, the health outcomes and adverse events. Continuous variables will be 
expressed as mean ± SD, while discrete variables will be shown as percentages. A 
two-tailed p value <0.05 will be considered statistically significant. Between-
group comparisons will be made using the independent t-test (for 2 groups) or the 
ANOVA (for >2 groups). Chi-squared tests will be used to evaluate relationship 
of two categorical variables. Logistic regression analysis will be performed to 
determine the association between health outcomes (ordinal scale, length of 
hospital stay, ICU days, death) and risk factors, adjusted for age and PaO2:FiO2 
ratio.
N.
Data and Safety Monitoring Plan 
Due to the urgent need for effective treatment, an internal data and safety 
monitoring board will be appointed for monitoring the trial progress. The board 
includes all project investigators. The board members will meet once per month, 
usually by teleconference, to review data from this trial. The board is also 
responsible for review of related issues, such as center performance standards. 
The board may request more frequent meetings if necessary to fulfill its charge. It 
may also request additional safety reports on a more frequent basis. The data 
board will review includes participants’ health outcome data such as ventilator 
support, hospital or ICU length of stay, death, dexamethasone adverse events, 
such as uncontrolled hyperglycemia requiring insulin infusion, severe infection 
etc. After each meeting, the board will make formal recommendations regarding 
trial continuation and clinical performance. A special responsibility of the board is 
to review serious adverse events (SAEs), as defined by deaths, life threatening 
conditions, or events requiring permanent discontinuation of the treatment. SAEs 
are to be documented on case report forms and reported to the primary 
investigator within 24 hours of notice, with follow up reporting until the event has 
terminated. The SAEs will also be submitted to OUHSC IRB in a timely fashion 
for review. According to other clinical trial using the high dose dexamethasone, 
the risk of insulin use, new diagnosis of infection and SAEs were similar between 
intervention and placebo. (5)  However, if the high dose dexamethasone group has 
statistically significant worse health outcome compared to the control group, it 
might trigger an immediate suspension of the study. 
At the end of each board meeting, the board will vote whether to continue the 
study as planned or whether to recommend changes to the study. The board may 

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recommend that the study be stopped early if there is evidence that the risk-
benefit ratio does not warrant continuation of the trial.
O.
Data Sharing
Data will not be shared with outside entity.
P.
Confidentiality 
The signed consent and HIPAA Forms will be kept in patient room if patients 
signed the forms or will be placed in the hospital confidential file box to be 
shredded after the document images are taken. Only electronic data will be 
collected. The data (identifiable and de-identified) will be stored in a secured 
server and REDCap in OUHSC. Only the study team members have the access to 
the server and review the data. Patients’ personal information will not be released 
to public. The de-identified data for final analysis will be stored in this secured 
server for future research after this study is closed. The identifiable data will be 
stored for two years after the study is completed and will be deleted permanently 
by OUHSC IT department. 
Q.
Literature Cited
1.
WHO. Global research on coronavirus disease (COVID-19). 2020. Available 
from: https://www.who.int/emergencies/diseases/novel-coronavirus-2019/global-
research-on-novel-coronavirus-2019-ncov. Accessed Jan 1, 2021
2.
WHO. Coronavirus disease (COVID-19) technical guidance: The Unity Studies: 
Early Investigation Protocols. 2020. Available from:  
https://www.who.int/emergencies/diseases/novel-coronavirus-2019/technical-
guidance/early-investigations. Accessed Jan 1, 2021
3.
Johns Hopkins Coronavirus Resource Center.  Available from: 
https://coronavirus.jhu.edu. Accessed Jan 1, 2021
4.
Horby P, Lim WS, Emberson JR, Mafham M, Bell JL, Linsell L, Staplin N, 
Brightling C, Ustianowski A, Elmahi E, Prudon B, Green C, Felton T, Chadwick D, Rege 
K, Fegan C, Chappell LC, Faust SN, Jaki T, Jeffery K, Montgomery A, Rowan K, 
Juszczak E, Baillie JK, Haynes R, Landray MJ. Dexamethasone in Hospitalized Patients 
with Covid-19 - Preliminary Report. N Engl J Med. 2020. Epub 2020/07/18. doi: 
10.1056/NEJMoa2021436. PubMed PMID: 32678530; PMCID: PMC7383595.
5.
Tomazini BM, Maia IS, Cavalcanti AB, Berwanger O, Rosa RG, Veiga VC, 
Avezum A, Lopes RD, Bueno FR, Silva M, Baldassare FP, Costa ELV, Moura RAB, 
Honorato MO, Costa AN, Damiani LP, Lisboa T, Kawano-Dourado L, Zampieri FG, 
Olivato GB, Righy C, Amendola CP, Roepke RML, Freitas DHM, Forte DN, Freitas 
FGR, Fernandes CCF, Melro LMG, Junior GFS, Morais DC, Zung S, Machado FR, 
Azevedo LCP. Effect of Dexamethasone on Days Alive and Ventilator-Free in Patients 
With Moderate or Severe Acute Respiratory Distress Syndrome and COVID-19: The 
CoDEX Randomized Clinical Trial. Jama. 2020;324(13):1307-16. Epub 2020/09/03. doi: 
10.1001/jama.2020.17021. PubMed PMID: 32876695; PMCID: PMC7489411 

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6.
Force OC-TT. OUHSC interim guidance for mangement of COVID-19 in adults 
pharmacotherapy information. Version 8.
7.
Dexamethasone sodium phosphate injection label  [updated May 2014Jan 1, 
2021]. Available from: 
https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/040572s002lbl.pdf. 
Accessed Jan 1, 2021