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

NCT04847141 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: GC20102021-000269-34
• Study Type: interventional
• Target: 465
• Locations: 1 country
• Sites: 12

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.

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Asymptomatic Participants Who Remained Asymptomatic, i.e., Who Did Not Develop Symptomatic COVID-19 Through Day 14

  Participants were described as symptomatic if they a. experienced at least two of the following systemic symptoms: fever (≥38 ºC), chills, myalgia, headache, sore throat, cough, fatigue that interferes with activities of daily living, new olfactory/taste disorder(s), and vomiting/diarrhea, b. experienced at least one of the following respiratory signs/symptoms: new or worsening shortness of breath or difficulty breathing; c. experienced a peripheral oxygen saturation by pulse oximetry (SpO2) \<94% on room air; or d. had radiographical evidence of pneumonia. The percentage of participants who meet the primary endpoint within each treatment group was presented along with a two-sided exact (Clopper-Pearson) 95% confidence interval (CI).

  Up to Day 14

Secondary Outcomes (21)

• Change From Baseline in SARS-CoV-2 Viral Load (log10 Copies/mL)

  Baseline to Day 7 and Day 14

• Percentage of Participants Who Remained in an Outpatient Setting and Maintained SpO2 ≥94% on Room Air on Day 3, Day 7, and Day 14

  Day 3, Day 7, and Day 14

• Percentage of Participants Negative for SARS-CoV-2 by Polymerase Chain Reaction (PCR) Test at Multiple Timepoints Through Day 14 and Through Day 29

  Day 3, Day 7, Day 14, and Day 29

• Time to Negative SARS-CoV-2 PCR From Baseline Through Day 29

  Baseline to Day 29

• Percentage of Participants Who Required Oxygen (O2) Supplementation on or Before Day 29

  Up to Day 29

Study Arms (3)

C19-IG 20% 1 g

EXPERIMENTAL

Participants will receive 1 gram (g) of C19-IG 20% subcutaneous (SC) infusion containing one syringe of 5 milliliters (mL) C19-IG 20% plus one syringe of 5 mL sterile 0.9% sodium chloride (NaCl) on Day 1.

Biological: C19-IG 20%; Drug: 0.9% Sodium chloride

C19-IG 20% 2 g

EXPERIMENTAL

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

Biological: C19-IG 20%

Placebo

PLACEBO COMPARATOR

Participants will receive C19-IG 20% matching placebo as SC infusion containing two syringes of 5 mL each sterile 0.9% NaCl injection on Day 1.

Drug: 0.9% Sodium chloride

Interventions

C19-IG 20% BIOLOGICAL

Anti-COVID-19 Immune Globulin (Human) 20%

C19-IG 20% 1 g; C19-IG 20% 2 g

0.9% Sodium chloride DRUG

C19-IG 20% matching placebo

C19-IG 20% 1 g; Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.
• Pulse oximetry peripheral oxygen saturation (SpO2) (oxygen saturation) on room air \> 94% (i.e., 95% to 100%) at Screening.
• National Early Warning Score (NEWS) ≤ 2 points at Screening.
• Participant provides informed consent (ICF) prior to initiation of any study procedures.

You may not qualify if:

• Participants who are admitted to hospital or for whom hospital admission is being planned at the time of Screening.
• Participants requiring any form of oxygen supplementation at Screening.
• Concurrent or planned treatment with other agents with actual or possible direct antiviral activity against SARS-CoV-2 including remdesivir.
• Prior, concurrent or planned treatment with monoclonal antibodies (mAbs) against SARS-CoV-2
• 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.
• Have a history of convalescent COVID-19 plasma treatment at Screening.
• 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.
• 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.
• 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.
• 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.
• Participants for whom there is limitation of therapeutic effort such as "Do not resuscitate" status.
• Currently participating in another interventional clinical trial with investigational medical product or device.
• Participants with known (documented) thrombotic complications to polyclonal intravenous immune globulin (IVIG) therapy in the past.
• Participant has medical condition (other than COVID-19) that is projected to limit lifespan to ≤ 1 year.
• Participant has history of drug or alcohol abuse within the past 12 months.

Sponsors & Collaborators

• Grifols Therapeutics LLC: lead

Study Sites (12)

CAP Gornal

L'Hospitalet de Llobregat, Barcelona, 08902, Spain

Location

CAP Navàs

Navàs, Barcelona, 08670, Spain

Location

CAP Sant Fèlix

Sabadell, Barcelona, 08024, Spain

Location

Centro de Salud Nuestra Señora del Pilar

Alcalá de Henares, Madrid, 28801, Spain

Location

Centro de Salud Presentación Sabio

Móstoles, Madrid, 28933, Spain

Location

CAP Manso

Barcelona, 08015, Spain

Location

CAP Maluquer Salvador

Girona, 17002, Spain

Location

Centro de Salud San Andrés

Madrid, 28021, Spain

Location

Centro de Salud Fuentelarreina

Madrid, 28035, Spain

Location

Centro de Salud Hacienda de Pavones Sureste

Madrid, 28108, Spain

Location

Centro de Salud Isla de Oza Noroeste

Madrid, 28108, Spain

Location

Hospital Sant Pau i Santa Tecla

Tarragona, 43003, Spain

Location

Related Publications (1)

• Alemany A, Millat-Martinez P, Corbacho-Monne M, Suner C, Galvan-Casas C, Carrera C, Ouchi D, Prat N, Ara J, Nadal N, Riel R, Funollet B, Ojeda-Ciurana C, Balague LE, Salvador-Gonzalez B, Arcarons AF, Vidal-Alaball J, Del Cura-Gonzalez MI, Barrientos RR, Ramos-Blanes R, Bou AA, Mondou E, Torres M, Campins N, Sanz A, Tang Y, Rodriguez-Arias MA, Bassat Q, Clotet B; GC2010 STUDY GROUP; Mitja O. Subcutaneous anti-COVID-19 hyperimmune immunoglobulin for prevention of disease in asymptomatic individuals with SARS-CoV-2 infection: a double-blind, placebo-controlled, randomised clinical trial. EClinicalMedicine. 2023 Mar 10;57:101898. doi: 10.1016/j.eclinm.2023.101898. eCollection 2023 Mar.

  PMID: 36936402 DERIVED

MeSH Terms

Conditions

COVID-19; Infections

Interventions

Sodium Chloride

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Limitations and Caveats

The study was terminated for futility.

Results Point of Contact

• Title: Mireia Torres
• Organization: Sr Manager, Clinical Research, Scientific Innovation Office (SIO)

mireia.torres@grifols.com

+34 93 5710500

Study Officials

• Oriol Mitjà, MD

  omitja@lluita.org, +3493 4978339

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2021
• First Posted: April 19, 2021
• Study Start: April 28, 2021
• Primary Completion: November 10, 2021
• Study Completion: December 27, 2021
• Last Updated: December 5, 2022
• Results First Posted: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ES (12)