kela-cov: Melatonin, Vitamins and Minerals Supplements for the Treatment of Covid-19 and Covid-like Illness
Study Details
Study Description
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
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
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 Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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 |
Drug: 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 Comparator: placebo Patients from the placebo group received three similar pills |
Drug: 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
|
Outcome Measures
Primary Outcome Measures
- mortality rate [30 days after inclusion]
death rate
- need for ICU admission [30 days after inclusion]
Number of participants admitted to the intensive care unit
- combined outcome [30 days after inclusion]
death or need for admission to the ICU for COVID-19 related complications
Secondary Outcome Measures
- Date of disappearance of symptoms present on admission [30 days after inclusion]
Date of disappearance of symptoms present on admission
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | CHU sahloul | Sousse | Tunisia |
Sponsors and Collaborators
- Hôpital Universitaire Sahloul
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- kelavit