ADAPTATIVE PLATFORM TREATMENT TRIAL FOR OUTPATIENTS WITH COVID-19 (ADAPT OUT COVID)

Not Applicable

• Conditions: -J39; J39

• Registration Number: PER-084-20
• Lead Sponsor: Instituto Nacional de Alergias y Enfermedades Infecciosas (NIAID). EEUU,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-11-27
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1) Ability and willingness of participant (or legally authorized representative) to provide informed consent.
2) Individuals ≥18 years of age.
3) 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.
4) 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.
5) One or more of the following signs/symptoms present within 48 hours prior to study entry (fever, cough, shortness of breath or difficulty breathing, sore throat, body pain, fatigue, headache, etc.)
6) Oxygenation saturation of ≥92% obtained at rest by study staff within 48 hours prior to study entry.
7) 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
8) Additional inclusion criteria as appropriate for the investigational agent.
For more details check the protocol.

Exclusion Criteria

1) History of or current hospitalization for COVID-19
2) Current need for hospitalization or immediate medical attention in the clinical opinion of the site investigator.
3) Use of any prohibited medication listed in the protocol within 30 days prior to study entry.
4) Receipt of convalescent COVID-19 plasma treatment at any time prior to study entry.
5) Receipt of a SARS-CoV-2 vaccine at any time prior to study entry.
6) Receipt of other available investigational treatments for SARS-CoV-2 at any time prior to study entry.
7) Receipt of systemic steroids (e.g., prednisone, dexamethasone) or inhaled steroids within 30 days prior to study entry
8) Known allergy/sensitivity or any hypersensitivity to components of the investigational agent or placebo
9) Any co-morbidity requiring surgery within 7 days prior to study entry
10) Additional exclusion criteria as appropriate for the investigational agent.
For more details check the protocol.

Study & Design

• Study Type: Interventional
• Study Design: Not specified