Status:
TERMINATED
A Study to Evaluate the Safety and Efficacy of C19-IG 20% in SARS-CoV-2 Infected Asymptomatic Ambulatory Outpatients
Lead Sponsor:
Grifols Therapeutics LLC
Conditions:
COVID-19
Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 re...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
- Participant is unwilling to commit to follow-up visits.
- 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.
Key Trial Info
Start Date :
April 28 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 27 2021
Estimated Enrollment :
465 Patients enrolled
Trial Details
Trial ID
NCT04847141
Start Date
April 28 2021
End Date
December 27 2021
Last Update
December 5 2022
Active Locations (12)
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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