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/2022/01/039426

Lead Sponsor: ational Institute of Allergy and Infectious Diseases

Brief Summary: Not available

Detailed Description: Not available

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. 4.1.1.3 Documentation of laboratory-confirmed SARS-CoV-2 infection, as determined by a molecular (nucleic acid) or antigen test from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected =240 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 7 days from self-reported onset of COVID-19 related symptoms or measured fever, where the first day of symptoms is considered symptom day 0 and defined by 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 >38°C

One or more of the following signs/symptoms present within 24 hours prior to study entry:

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

nausea or vomiting

diarrhea

documented temperature >38°C

Oxygenation saturation of =92% obtained at rest by study staff within 24 hours prior to study entry. For a potential participant who regularly receives chronic supplementary oxygen for an underlying lung condition their oxygen saturation should be measured while on their standard home oxygen supplementation level.

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

For participants who are of reproductive potential, negative serum or urine pregnancy test 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.

Reproductive potential is defined as:

participant who has reached menarche

participant who has not been post-menopausal for at least 12 consecutive months with follicle-stimulating hormone (FSH) level =40 IU/mL or 24 consecutive months if an FSH result is not

available participant who has not undergone surgical sterilization (e.g., hysterectomy, bilateral oophorectomy, bilateral tubal

ligation,or bilateral salpingectomy)

participant with no other clinical condition

Exclusion Criteria

History of or current hospitalization for COVID-19.

For the current SARS-CoV-2 infection, any positive SARS-CoV-2 nucleic acid or antigen tests from any respiratory tract specimen (e.g., oropharyngeal, NP, or nasal swab, or saliva) collected ?240 hours prior to study entry.

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 and/or use of systemic or inhaled steroids for the purpose of COVID-19 treatment (new or increased dose from chronic baseline) within 30 days prior to study entry.

Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis 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. NOTE:

This does not include COVID-19 vaccines.

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.

Currently pregnant

Currently breastfeeding