ACTIV-2 –Adaptive Platform Treatment Trial for Outpatients with COVID-19

The purpose of this study is to evaluate the ability of various experimental drugs to improve health outcomes for people with COVID-19. We also want to see if these study drugs are safe, and if these study drugs can stop the disease process and prevent hospitalization. This study is designed to quickly identify safe and effective drugs that may treat COVID-19.

Inova Fairfax Medical Campus
3300 Gallows Rd.
Falls Church, VA 22042

• 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, collected within 7 days prior to study entry
• Participants must be expected to begin study treatment no more than 10 days from self-reported onset of COVID-19 related symptoms
• One or more of the following signs/symptoms present within 48 hours prior to study entry: Fever or feeling feverish, cough, shortness of breath or difficulty breathing, sore throat, body pain or muscle aches, fatigue, headache, chills, nasal obstruction or congestion, nasal discharge, nausea or vomiting, diarrhea, documented temperature >37.8C (100F)
• Oxygenation saturation of >92% obtained at rest by study staff within 48 hours prior to study entry, unless the potential participant regularly received chronic supplementary oxygen for an underlying lung condition.

• 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 of the following medications within 30 days prior to study entry: hydroxychloroquine, chloroquine, ivermectin, remdesivir, systemic and inhaled steroids (unless used chronically), and HIV protease inhibitors
• 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
• 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

ClinicalTrials.gov Identifier: NCT04518410