Clinical trial NCT04847141: A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients
Official title: A Multicenter, Randomized, Double-blind, Parallel Group Study to Evaluate the Safety and Efficacy of Anti-COVID-19 Immune Globulin (Human) 20% (C19-IG 20%) Versus Placebo in Asymptomatic Ambulatory Outpatients With Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: COVID-19
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Keywords: Coronavirus disease
Severe acute respiratory syndrome coronavirus 2
SARS-CoV-2
COVID-19
Asymptomatic
Lead sponsor: Grifols Therapeutics LLC
Sponsor class: INDUSTRY
First posted: 2021-04-19
Enrollment: 465
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the efficacy of anti-COVID-19 immune globulin (human) 20% (C19-IG 20%) (2 doses) versus placebo with regard to the percentage of asymptomatic participants who remain asymptomatic, i.e., who do not develop symptomatic coronavirus disease 2019 (COVID-19) through Day 14 as per the protocol defined criteria.


Eligibility criteria: Inclusion Criteria:

1. Ambulatory male or female outpatients ≥ 18 years of age who have laboratory-confirmed severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection as determined by qualitative PCR (reverse transcriptase (RT)-PCR), or other commercial or public health assay approved by regulatory authorities as a diagnostic test for COVID-19 (inclusive of SARS-CoV-2 antigen testing or other approved rapid testing platforms) in any specimen ≤ 5 days prior to randomized treatment.
2. Asymptomatic with no constitutional COVID-19 illness (evident symptoms), specifically no fever, cough, shortness of breath, fatigue, anorexia, vomiting/diarrhea, headache that is unrelated to pre-existing conditions (example, migraine), sore throat that is unrelated to other pre-existing medical conditions (example, allergies, gastroesophageal reflux disease), myalgias, olfactory disorders unrelated with previous medical condition, or evidence of pneumonia at Screening.
3. Pulse oximetry peripheral oxygen saturation (SpO2) (oxygen saturation) on room air \> 94% (i.e., 95% to 100%) at Screening.
4. National Early Warning Score (NEWS) ≤ 2 points at Screening.
5. Participant provides informed consent (ICF) prior to initiation of any study procedures.

Exclusion Criteria:

1. Participants who are admitted to hospital or for whom hospital admission is being planned at the time of Screening.
2. Participants requiring any form of oxygen supplementation at Screening.
3. Concurrent or planned treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including remdesivir.
4. Prior, concurrent or planned treatment with monoclonal antibodies (mAbs) against SARS-CoV-2
5. Have participated in a previous SARS-CoV-2 vaccine study OR outside of a study have received any SARS-CoV-2 vaccine of any kind.
6. Have a history of convalescent COVID-19 plasma treatment at Screening.
7. Fever (temperature ≥38.0° C \[≥100.4° F\]), measured orally, requirement for antipyretics to reduce temperature (administered for fever), and/or respiratory symptoms (cough, dyspnea) at Screening.
8. Clinical evidence of any significant acute or chronic disease that, in the opinion of the investigator, may place the participant at undue medical risk for study treatment.
9. The participant has had a known (documented) history of serious anaphylactic reaction to blood, any blood-derived plasma product or commercial immunoglobulin, or has known selective immunoglobulin A (IgA) deficiency with anti-IgA antibodies.
10. Decompensated congestive heart failure or renal failure with fluid overload. This includes currently uncontrolled congestive heart failure New York Heart Association Class III or IV stage heart failure.
11. Participants for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
12. Currently participating in another interventional clinical trial with investigational medical product or device.
13. Participants with known (documented) thrombotic complications to polyclonal intravenous immune globulin (IVIG) therapy in the past.
14. Participant has medical condition (other than COVID-19) that is projected to limit lifespan to ≤ 1 year.
15. Participant has history of drug or alcohol abuse within the past 12 months.
16. Participant is unwilling to commit to follow-up visits.
17. Women who are pregnant or breastfeeding, or if of childbearing potential, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device or intrauterine system, condom, or occlusive cap with spermicidal foam/gel/cream/suppository, male sterilization, or true abstinence) throughout the study.

    * True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \[e.g., calendar, ovulation, symptothermal, post-ovulation methods\], declaration of abstinence for the duration of a trial, and withdrawal are not acceptable methods of contraception).
    * Note: Women who are \>55 years and with the absence of menses in the last 12 months are considered to be not of childbearing potential. Female participants of childbearing potential must have a negative test for pregnancy blood or urine human chorionic gonadotropin (hCG)-based assay at Screening/Baseline Visit.

Primary outcomes:
measure: Percentage of Asymptomatic Participants Who Remained Asymptomatic, i.e., Who Did Not Develop Symptomatic COVID-19 Through Day 14
timeFrame: Up to Day 14
Secondary outcomes:
measure: Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL)
timeFrame: Baseline to Day 7 and Day 14
measure: Percentage of Participants Who Remained in an Outpatient Setting and Maintained SpO2 ≥94% on Room Air on Day 3, Day 7, and Day 14
timeFrame: Day 3, Day 7, and Day 14
measure: Percentage of Participants Negative for SARS-CoV-2 by Polymerase Chain Reaction (PCR) Test at Multiple Timepoints Through Day 14 and Through Day 29
timeFrame: Day 3, Day 7, Day 14, and Day 29
measure: Time to Negative SARS-CoV-2 PCR From Baseline Through Day 29
timeFrame: Baseline to Day 29
measure: Percentage of Participants Who Required Oxygen (O2) Supplementation on or Before Day 29
timeFrame: Up to Day 29
measure: Duration of Any Oxygen Use Through Day 29
timeFrame: Up to Day 29
measure: Absolute Value Score on a 7-point Ordinal Scale
timeFrame: Baseline, Day 7, 14, and 29
measure: Mean Change From Baseline in the 7-point Ordinal Scale
timeFrame: Baseline to Day 7, Day 14, and Day 29
measure: Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale
timeFrame: Days 1, 7, 14, and 29
measure: Change From Baseline in National Early Warning Score (NEWS)
timeFrame: Baseline to Day 7, Day 14, and Day 29
measure: Percentage of Participants Who Required At Least One COVID-19 Related Medically Attended Visit (MAV) for Management/Treatment of COVID-19 Which May Have Occurred in Any Setting Through Day 29
timeFrame: Up to Day 29
measure: Percentage of Participants Who Required Hospital Admission for Medical Care (Non-Quarantine Purposes) Through Day 29
timeFrame: Up to Day 29
measure: Duration of Hospital Stay Through Day 29
timeFrame: Up to Day 29
measure: Percentage of Participants Who Required Intensive Care Unit (ICU) Admission or Initiation of ICU Level Care Through Day 29
timeFrame: Up to Day 29
measure: Duration of ICU Stay Through Day 29
timeFrame: Up to Day 29
measure: Percentage of Participants Requiring Invasive Mechanical Ventilation Through Day 29
timeFrame: Up to Day 29
measure: Duration of Invasive Mechanical Ventilation Through Day 29
timeFrame: Up to Day 29
measure: All-Cause Mortality Through Day 29
timeFrame: Up to Day 29
measure: Percentage of Participants With Critical COVID-19 Illness
timeFrame: Up to Day 29
measure: Length of Time to Clinical Progression to Critical COVID-19 Illness Through Day 29
timeFrame: Up to Day 29
measure: Time to COVID-19 Symptoms Through Day 14
timeFrame: Up to Day 14
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: CAP Gornal
state: Barcelona
city: Navàs
country: Spain
facility: CAP Navàs
state: Barcelona
city: Sabadell
country: Spain
facility: CAP Sant Fèlix
state: Barcelona
city: Alcalá de Henares
country: Spain
facility: Centro de Salud Nuestra Señora del Pilar
state: Madrid
city: Móstoles
country: Spain
facility: Centro de Salud Presentación Sabio
state: Madrid
city: Barcelona
country: Spain
facility: CAP Manso
city: Girona
country: Spain
facility: CAP Maluquer Salvador
city: Madrid
country: Spain
facility: Centro de Salud San Andrés
city: Madrid
country: Spain
facility: Centro de Salud Fuentelarreina
city: Madrid
country: Spain
facility: Centro de Salud Hacienda de Pavones Sureste
city: Madrid
country: Spain
facility: Centro de Salud Isla de Oza Noroeste
city: Tarragona
country: Spain
facility: Hospital Sant Pau i Santa Tecla
Study officials:
affiliation: omitja@lluita.org, +3493 4978339
name: Oriol Mitjà, MD
role: PRINCIPAL_INVESTIGATOR
References: