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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05670444
Acronym
kela-cov
Enrollment
150
Registered
2023-01-04
Start date
2023-01-02
Completion date
2023-02-28
Last updated
2023-03-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza -Like Illness

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

Interventions

DRUGkelavit

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

Sponsors

Hôpital Universitaire Sahloul
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Intervention model description

multicenter, randomized , placebo-controlled trial

Eligibility

Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
combined outcome30 days after inclusiondeath or need for admission to the ICU for COVID-19 related complications
mortality rate30 days after inclusiondeath rate
need for ICU admission30 days after inclusionNumber of participants admitted to the intensive care unit

Secondary

MeasureTime frameDescription
number of participants requiring hospitalization due to COVID- infection30 days after inclusionnumber of participants requiring hospitalization due to COVID- infection
Date of disappearance of symptoms present on admission30 days after inclusionDate of disappearance of symptoms present on admission
number of participants requiring respiratory support or hospitalization30 days after inclusionnumber of participants requiring respiratory support or hospitalization
appearance of an adverse effect due to the administration of the treatment30 days after inclusionappearance of an adverse effect due to the administration of the treatment
number of patients developing complications30 days after inclusionnumber of patients developing complications

Countries

Tunisia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026