Clinical trial

Melatonin, Vitamins and Minerals Supplements for the Treatment of Covid-19 and Covid-like Illness: Results of a Prospective, Randomised, Double-blinded Multicentre Study

Name
kelavit
Description
a multicenter, double-blind, randomized, placebo-controlled trial. Patients aged less than 60 years old with no previous medical history consulting the emergency department for covid and covid-like illness and who were not hospitalized were included. Those who have known allergy or severe side effect on the study drugs and those who refused to consent were excluded. Pregnant women were not included. For all the included patients, a PCR test for the detection of SARS COV2 was realized. Patients were assigned in a 1:1 ratio to the treatment group or the placebo group. The treatment group received two pills in the morning containing Vit C Vit D zinc and minerals and one pill of 2 mg of melatonin in the evening . Patients from the placebo group received three similar pills . The pills were identical in color, taste, smell, consistency, and container
Trial arms
Trial start
2023-01-02
Estimated PCD
2023-02-28
Trial end
2023-02-28
Status
Completed
Phase
Early phase I
Treatment
kelavit
The treatment group received two pills in the morning containing Vit C Vit D zinc and minerals and one pill of 2 mg of melatonin in the evening
Arms:
kelavit, placebo
Size
150
Primary endpoint
mortality rate
30 days after inclusion
need for ICU admission
30 days after inclusion
combined outcome
30 days after inclusion
Eligibility criteria
Inclusion Criteria: * Patients aged less than 60 years old * no previous medical history * consulting the emergency department for covid and covid-like illness * not hospitalized Exclusion Criteria: * allergy or severe side effect on the study drugs * refused to consent * Pregnant women
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE1'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'multicenter, randomized , placebo-controlled trial', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 150, 'type': 'ACTUAL'}}
Updated at
2023-03-29

1 organization

1 product

1 indication

Product
kelavit