Fluvoxamine Administration in Moderate SARS-CoV-2 (COVID-19) Infected Patients
NCT04718480 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 66
Last updated 2022-08-23
Summary
This is a randomized, double-blind, placebo-controlled, adaptive two-stage design, human phase 2 study, with add-on treatment arrangement of fluvoxamine or placebo on top of standard of care (base therapy: the actual proposed therapy of moderate SARS-CoV-2 infected patients according to "Hungarian Coronavirus Handbook", including antiviral and immunmodulant therapy and reconvalescent plasma therapy in serious cases as indicated by the investigator).
Conditions
- Covid19
Interventions
- DRUG
-
po placebo tablets
- DRUG
-
Fluvoxamine
po fluvoxamine tablets
Sponsors & Collaborators
-
SigmaDrugs Research Ltd.
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-11-27
- Primary Completion
- 2022-03-15
- Completion
- 2022-05-31
Countries
- Hungary
Study Locations
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