Adaptive Platform Treatment Trial for Outpatients with COVID-19 (Adapt Out COVID)

Phase 3

• Conditions: Respiratory

• Registration Number: PACTR202111591363732
• 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
• Study Start: 2021-11-11
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 1600

Inclusion Criteria

General Eligibility Criteria

1.1.1Inclusion Criteria

1.1.1.1Ability and willingness of participant (or legally authorized representative) to provide informed consent prior to initiation of any study procedures.

1.1.1.2Individuals =18 years of age.

1.1.1.3Documentation 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.

1.1.1.4Participants 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

1.1.1.5One 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

1.1.1.6Oxygenation 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 saturati

Exclusion Criteria

1.1.1Exclusion Criteria

1.1.1.1History of or current hospitalization for COVID-19.

1.1.1.2For 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.

1.1.1.3Current need for hospitalization or immediate medical attention in the clinical opinion of the site investigator.

1.1.1.4Use 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.

1.1.1.5Receipt of convalescent COVID-19 plasma or other antibody-based anti-SARS-CoV-2 treatment or prophylaxis at any time prior to study entry.

1.1.1.6Receipt 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.
1.1.1.7Known allergy/sensitivity or any hypersensitivity to components of the investigational agent or placebo. See relevant appendix.

1.1.1.8Any 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.

1.1.1.9Additional exclusion criteria as appropriate for the investigational agent (see relevant appendix/appendices).

Study & Design

• Study Type: Interventional
• Study Design: Not specified