A study in non-hospitalized COVID-19 patients to assess safety and effectiveness of study drug.

Phase 3

• Conditions: Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere

• Registration Number: CTRI/2021/05/033740
• Lead Sponsor: ational Institute of Allergy and Infectious Diseases

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 18 September 2023

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures.

Individuals =18 years of age.

Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular test(antigen or nucleic acid) from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected =168 hours prior to study entry and conducted at any US clinic or laboratory that has a Clinical Laboratory Improvement Amendments (CLIA) certification or its equivalent or any non-US DAIDS-approved laboratory.

Participants must be expected to begin study treatment no more than 10 days from self-reported onset of COVID-19 related symptoms or measured fever, defined as the self-reported date of first reported sign/symptom from the following list:

subjective fever or feeling feverish

cough

shortness of breath or difficulty breathing at rest or with activity

sore throat

body pain or muscle pain/aches

fatigue

headache

chills

nasal obstruction or congestion

nasal discharge

loss of taste or smell

nausea or vomiting

diarrhea

documented temperature >37.8°C

One or more of the following signs/symptoms present within 48 hours prior to study entry:

subjecive fever or feeling feverish

cough

shortness of breath or difficulty breathing at rest or with activity

sore throat

body pain or muscle pain/aches

fatigue

headache

chills

nasal obstruction or congestion

nasal discharge

nausea or vomiting

diarrhea

documented temperature >37.8°C

Oxygenation saturation of =92% obtained at rest by study staff within 48 hours prior to study entry, unless the potential participant regularly receives chronic supplementary oxygen for an underlying lung condition.

Agrees to not participate in another clinical trial for the treatment of COVID-19 or SARS-CoV-2 during the study period until reaching hospitalization or 28 days post-entry, whichever is earliest. •Additional inclusion criteria as appropriate for the investigational agent (see relevant appendix/appendices).

For participants who are of reproductive potential, negative serum or urine pregnancy test at within 48 hours prior to study entry by any clinic or laboratory that has a CLIA certification or its equivalent, or by a point of care (POC)/CLIA-waived test.

If participating in sexual activity that could lead to pregnancy, participants who are of reproductive potential must agree to use two forms of effective contraception, where at least one form is highly effective (less than 1% failure rate), for the entirety of the study and for 90 days after investigational agent is administered.

Participants that engage in sexual activity that may lead to pregnancy in their partner must agree to either remain abstinent or use male or female condoms with spermicide as well as one additional form of effective contraception with non-pregnant sexual partners of reproductive potential, for the entirety of the study and for 90 days after investigational agent is administered .

as well as the appropriate inclusion for the investigational agent included below;

A. Meet the protocol definition of being at high? ris

Exclusion Criteria

History of or current hospitalization for COVID-19.

Current need for hospitalization or immediate medical attention in the clinical opinion of the site investigator.

Use of any prohibited medication listed in section 5.4.1 within 30 days prior to study entry.

Receipt of convalescent COVID-19 plasma treatment at any time prior to study entry.

Receipt of a SARS-CoV-2 vaccine at any time prior to study entry.

Receipt of other available investigational treatments for SARS-CoV-2 at any time prior to study entry. This does not include drugs approved for other uses and taken for those uses.

Receipt of systemic steroids (e.g., prednisone, dexamethasone) or inhaled steroids within 30 days prior to study entry unless a stable dose used for a chronic condition.

Known allergy/sensitivity or any hypersensitivity to components of the investigational agent or placebo. See relevant appendix.

Any co-morbidity requiring surgery within 7 days prior to study entry, or that is considered life threatening in the opinion of the site investigator within 30 days prior to study entry.

Additional exclusion criteria as appropriate for the investigational agent (see relevant appendix/appendices).

Currently pregnant

Currently breastfeeding

Profile of probands: age, sex, race, health status, co-medication

Male and female individuals =18 years of age as detailed above.

Participants must meet above inclusion and exclusion criteria from the master protocol.

exclusion criteria for the investigational

agent included below: . Currently pregnant or breastfeeding

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Death from any cause or hospitalization during the 28-day period from and including the day of the first dose of investigational agent or placebo. Hospitalization is defined as equal or grater than 24 hours of acute care, in a hospital or similar acute care facility, including Emergency Rooms or temporary facilities instituted to address medical needs of those with severe COVID-19 during the COVID-19 pandemic.Timepoint: New Grade 3 or higher AE through 28 days

Secondary Outcome Measures

Name	Time	Method
The cumulative proportion of participants dying during the first 28 days of follow-up, and through to 24 weeks, and the cumulative proportion hospitalized/dying through to 24 weeks will be analyzed in a similar manner to the phase III primary outcome.Timepoint: New Grade 3 or higher AE(s) by week 24