COVID-19: A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients

Sponsor
Grifols Therapeutics LLC (Industry)
Overall Status
Terminated
CT.gov ID
NCT04847141
Collaborator
(none)
465
12
3
8
38.8
4.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Biological: C19-IG 20%
  • Drug: 0.9% Sodium chloride
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
465 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 28, 2021
Actual Primary Completion Date :
Nov 10, 2021
Actual Study Completion Date :
Dec 27, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: C19-IG 20% 1 g

Participants will receive 1 gram (g) of C19-IG 20% subcutaneous (SC) infusion containing one syringe of 5 mL C19-IG 20% plus one syringe of 5 mL 0.9% sodium chloride on Day 1 in a double-blind manner.

Biological: C19-IG 20%
Anti-COVID-19 Immune Globulin (Human) 20%

Drug: 0.9% Sodium chloride
C19-IG 20% matching placebo

Experimental: C19-IG 20% 2 g

Participants will receive 2 g of C19-IG 20% SC infusion containing two syringes 5 mL each of C19-IG 20% on Day 1 in a double-blind manner.

Biological: C19-IG 20%
Anti-COVID-19 Immune Globulin (Human) 20%

Placebo Comparator: Placebo

Participants will receive C19-IG 20% matching placebo as SC infusion containing two syringes of 5 mL each sterile 0.9% sodium chloride injection on Day 1 in a double-blind manner.

Drug: 0.9% Sodium chloride
C19-IG 20% matching placebo

Outcome Measures

Primary Outcome Measures

  1. Percentage of Asymptomatic Participants who Remain Asymptomatic, i.e., who do not Develop Symptomatic COVID-19 [Up to Day 14]

Secondary Outcome Measures

  1. Change from Baseline in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Viral Load (log10 copies/mL) [Day 1 to Day 7, and up to Day 14]

  2. Percentage of Participants who Remain in an Outpatient Setting and Maintain Peripheral Oxygen Saturation by Pulse Oximetry (SpO2) ≥94% on Room Air [Day 3, Day 7, and Day 14]

  3. Percentage of Participants Negative for SARS-CoV-2 by Polymerase Chain Reaction (PCR) [Up to Day 14, and up to Day 29]

  4. Time to Negative SARS-CoV-2 PCR [Baseline up to Day 29]

  5. Percentage of Participants who Require Oxygen (O2) Supplementation [Up to Day 29]

  6. Duration of Any Oxygen [Up to Day 29]

  7. Absolute Value Score on a 7-point Ordinal Scale [Day 1, Day 7, Day 14, and Day 29]

  8. Mean Change from Baseline in the 7-point Ordinal Scale [Day 1, Day 7, Day 14, and Day 29]

  9. Percentage of Participants in Each Severity Category of the 7-point Ordinal Scale [Day 1, Day 7, Day 14, and Day 29]

  10. Change from Baseline in National Early Warning Score (NEWS) [Day 1, Day 7, Day 14, and Day 29]

  11. Percentage of Participants who Require At Least One COVID-19 Related Medically Attended Visit for Management/Treatment of COVID-19 which may Occur in Any Setting [Up to Day 29]

  12. Percentage of Participants who Require Hospital Admission for Medical Care (Non-Quarantine Purposes) [Up to Day 29]

  13. Duration of Hospital Stay [Up to Day 29]

  14. Percentage of Participants who Require Intensive Care Unit (ICU) Admission or Initiation of ICU Level Care [Up to Day 29]

  15. Duration of ICU Stay [Up to Day 29]

  16. Percentage of Participants Requiring Invasive Mechanical Ventilation [Up to Day 29]

  17. Duration of Invasive Mechanical Ventilation [Up to Day 29]

  18. Number of Participants with All-Cause Mortality [Up to Day 29]

  19. Number of Participants with Critical COVID-19 Illness [Up to Day 29]

  20. Length of Time to Clinical Progression to Critical COVID-19 Illness [Up to Day 29]

  21. Time to COVID-19 Symptoms [Up to Day 14]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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. Subject provides informed consent (ICF) prior to initiation of any study procedures.

Exclusion Criteria:
  1. Subjects who are admitted to hospital or for whom hospital admission is being planned at the time of Screening.

  2. Subjects 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 subject at undue medical risk for study treatment.

  9. The subject 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. Subjects 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. Subjects with known (documented) thrombotic complications to polyclonal intravenous immune globulin (IVIG) therapy in the past.

  14. Subject has medical condition (other than COVID-19) that is projected to limit lifespan to ≤ 1 year.

  15. Subject has history of drug or alcohol abuse within the past 12 months.

  16. 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CAP Gornal L'Hospitalet de Llobregat Barcelona Spain 08902
2 CAP Navàs Navàs Barcelona Spain 08670
3 CAP Sant Fèlix Sabadell Barcelona Spain 08024
4 Centro de Salud Nuestra Señora del Pilar Alcalá de Henares Madrid Spain 28801
5 Centro de Salud Presentación Sabio Móstoles Madrid Spain 28933
6 CAP Manso Barcelona Spain 08015
7 CAP Maluquer Salvador Girona Spain 17002
8 Centro de Salud San Andrés Madrid Spain 28021
9 Centro de Salud Fuentelarreina Madrid Spain 28035
10 Centro de Salud Hacienda de Pavones Sureste Madrid Spain 28108
11 Centro de Salud Isla de Oza Noroeste Madrid Spain 28108
12 Hospital Sant Pau i Santa Tecla Tarragona Spain 43003

Sponsors and Collaborators

  • Grifols Therapeutics LLC

Investigators

  • Principal Investigator: Oriol Mitjà, MD, omitja@flsida.org, +3493 4978339

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Grifols Therapeutics LLC
ClinicalTrials.gov Identifier:
NCT04847141
Other Study ID Numbers:
  • GC2010
  • 2021-000269-34
First Posted:
Apr 19, 2021
Last Update Posted:
Feb 25, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Grifols Therapeutics LLC
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 25, 2022