CompletedPhase 2/3

Multicenter Double Blind, Parallel-group Phase 2/3 Trial, to Study Raloxifene in Adult COVID-19 Patients.

France, Italy61 participantsStarted 2021-01-22

Plain-language 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

Who can participate

Age range40 Years

SexALL

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Inclusion criteria

✓. Subject autonomously provides informed consent prior to initiation of any study procedures
✓. Males and females ≥ 40 years old
✓. Understands and agrees to comply with planned study procedures, has the availability of an email address as well as an Internet connection at domicile location
✓. Agrees to the collection of nasopharyngeal swabs and venous blood samples per protocol
✓. Has laboratory-confirmed SARS-CoV-2 infection as determined by an approved molecular test (PCR) in Europe within 10 days at the screening time
✓. Patient paucisymptomatic who complains at the screening time at least one of the following symptoms mild to moderate: fever, dyspnea, headache, cough, dysgeusia, conjunctivitis, vomiting, diarrhea, anosmia, muscle or body aches or other symptoms which in the opinion of the Investigator are part of the COVID-19 clinical picture
✓. No need of supplemental oxygen therapy, mechanical ventilation
✓. Females of child-bearing potential and with an active sexual life must not wish to get pregnant within 30 days after the end of the study and must be using at least one of the following reliable methods of contraception:

Exclusion criteria

What they're measuring

Number of Participants With Undetectable SARS-CoV-2 at PCR at Day 7 After Randomization in the FAS

Timeframe: At Day 7

Number of Participants Not Requiring Oxygen Therapy and/or Mechanical Ventilation at Day 14 After Randomization in the FAS

Timeframe: At Day 14

Trial details

NCT IDNCT05172050

SponsorDompé Farmaceutici S.p.A

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-06-12

Results submitted2022-06-06

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