Study to Evaluate the Efficacy of COVID19-0001-USR in Patients With Mild/or Moderate COVID-19 Infection in Outpatient
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- SARS CoV-2 Infection
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: Interventional study, randomized controlled, double-blind (i.e., active and passive control), 1 intervention group with investigative medicine, and a control group that will receive placebo intervention.Masking: Triple (Participant, Care Provider, Investigator)Masking Description: The mapping sequence will be hidden from the researcher by enrolling and evaluating participants in sequentially numbered, sealed, and stapled envelopes. To avoid the subversion of the allocation sequence, the name and date of birth of the participant will be written in the envelope, a second researcher verifies the process. The corresponding envelopes will be opened only after the enrolled participants complete all the reference assessments and assignment of the intervention by the protocolPrimary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
Description
This is an interventional, randomized controlled, double-blind study (i.e., active and passive control), 1 intervention group will be randomized with COVID 19-001-USR, and a control group to receive a placebo intervention to assess efficacy, tolerance, and decrease viral load and clinical manifestat...
This is an interventional, randomized controlled, double-blind study (i.e., active and passive control), 1 intervention group will be randomized with COVID 19-001-USR, and a control group to receive a placebo intervention to assess efficacy, tolerance, and decrease viral load and clinical manifestation on patients infected with SARS-COV-2. This will be a self-administered study drug 3 times a day for 7 days
Tracking Information
- NCT #
- NCT04595136
- Collaborators
- Not Provided
- Investigators
- Principal Investigator: Juan Jaller, MD United Medical Specialties Study Director: Carlos A Riveros, MD United Medical Specialties
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