Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.
Status:
Completed
Trial end date:
2021-06-12
Target enrollment:
Participant gender:
Summary
The objective of the study is to evaluate the efficacy and safety of two different doses of
raloxifene orally administered compared to placebo in patients with early diagnosis of
paucisymptomatic COVID-19.
Primary objectives:
- Evaluation of the effectiveness of therapy in reducing the proportion of subjects who
still have viruses in the upper airways after 7 days of therapy
- Evaluation of the effectiveness of therapy in reducing the proportion of subjects who
requires supplemental oxygen therapy and/or mechanical ventilation within 14 days of
starting therapy
Secondary objectives:
- Evaluation of the effectiveness of therapy in reducing the proportion of subjects who
still have viruses in the upper airways after 14 and 28 days of therapy
- Evaluation of the effectiveness of therapy in reducing the proportion of subject
patients who requires supplemental oxygen therapy and/or mechanical ventilation within 7
or 28 days of starting therapy
- 7, 14 and 28 days drug safety and tolerability profile
- Assessment of body temperature, blood and biochemical parameters between T0 and T28