Melatonin, Vitamins and Minerals Supplements for the Treatment of Covid-19 and Covid-like Illness

Phase 1

Completed

• Conditions: Influenza -Like Illness
• Interventions: Drug: kelavit

• Registration Number: NCT05670444
• Lead Sponsor: Hôpital Universitaire Sahloul

Brief Summary

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

Detailed Description

This was a multicenter, double-blind, randomized, placebo-controlled trial. The study was approved by the ethics committee of the the Faculty of Medicine "Ibn El Jazzar" of Sousse. Patients provided written informed consent before participation. Patients were recruited from Sahloul emergency department, F.Hached emergency department, F.Bourguiba emergency department. 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 randomization list was created using a computer-generated code. A staff member who had no role in the study managed the randomization. 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. They were prepared by XEn Plus laboratory members and labeled by a staff member who did not participate in the study. Patients and investigators remained blinded to randomization until the final analysis. After consenting, patients were examined by an emergency resident. They were asked about the common Covid-19 and Covid-like illness signs: fever, headache, asthenia/fatigue, sputum expectoration, anosmia, chills, skin rash, diarrhea, sore throat, abdominal pain, cough, vomiting, chest pain, hemoptysis, joint pain, ageusia, dyspnea, muscle pain and conjunctives. On physical examination vital signs were checked: blood pressure, pulse rate, respiration rate, body temperature, glycemic index, oxygen saturation and height and weight. This symptoms were assessed using a scale from 0 to 3 (not at all, slight, a lot, awful) and they were monitored via telecommunication. A follow-up was carried for each included patient on day 1, day 10, day 15 and day 30. Compliance with treatment, the date of disappearance of symptoms, side effects, adverse events, hospitalization, respiratory assistance requirement and death were mentioned accordingly

Study Timeline

• Study First Submitted: 2022-12-26
• Study First Submitted QC: 2023-01-01
• Study Start: 2023-01-02
• Study First Posted: 2023-01-04
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-27
• Last Update Posted: 2023-03-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

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Exclusion Criteria

• allergy or severe side effect on the study drugs
• refused to consent
• Pregnant women

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
kelavit	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
placebo	kelavit	Patients from the placebo group received three similar pills

Primary Outcome Measures

Name	Time	Method
combined outcome	30 days after inclusion	death or need for admission to the ICU for COVID-19 related complications
need for ICU admission	30 days after inclusion	Number of participants admitted to the intensive care unit
mortality rate	30 days after inclusion	death rate

Secondary Outcome Measures

Name	Time	Method
number of participants requiring hospitalization due to COVID- infection	30 days after inclusion	number of participants requiring hospitalization due to COVID- infection
number of participants requiring respiratory support or hospitalization	30 days after inclusion	number of participants requiring respiratory support or hospitalization
appearance of an adverse effect due to the administration of the treatment	30 days after inclusion	appearance of an adverse effect due to the administration of the treatment
number of patients developing complications	30 days after inclusion	number of patients developing complications
Date of disappearance of symptoms present on admission	30 days after inclusion	Date of disappearance of symptoms present on admission

Trial Locations

Locations (1)

CHU sahloul; 🇹🇳 Sousse, Tunisia