Date trial registered
Sep 28, 2020
Incorporation of the first participant
Nov 5, 2020
Recruitment status
Recruiting
Academic title
(Data source: WHO)
Evaluation of the Efficacy of Methylene Blue Administration in SARS-CoV2- Affected Patients: a Phase 2, Randomized, Placebo- Controlled, Single Blind Clinical Trial
Type of trial
(Data source: WHO)
Interventional
Design of the trial
(Data source: WHO)
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Care Provider, Investigator, Outcomes Assessor).
Phase
(Data source: WHO)
Phase 2
Primary end point
(Data source: WHO)
to compare the viral load kinetics in the enrolled patients with a SARS-CoV-2 positive nasopharyngeal swab demonstrating a reduction of the area under the curve day 0- day 21 of at least 25%
Secundary end point
(Data source: WHO)
To calculate the percentage of patients clearing SARS-CoV-2 by 3, 6, 9, 12, 15 and 21 days after diagnosis;To calculate the percentage of patients having a reduction of viral load of > 2 log by day 3;To calculate the percentage of patients having a poor outcome as measured by the need of hospitalization for COVID-19;To calculate the percentage of patients alive;Safety and tolerability of the administered drug are registered as adverse events, which are all symptoms related or supposed to be related to the drug that appeared after the drug intake and were NOT present at baseline or before;To measure the compliance by calculating the number of capsules taken by the patient and the overall number of patients who complete the treatment
Contact information
(Data source: WHO)
Please refer to primary and secondary sponsors
