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

Influenza -Like Illness Clinical Trial

— kela-cov  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05670444
• Other study ID #: kelavit
• Status: Completed
• Phase: Phase 1
• Start date: January 2, 2023
• Est. completion date: February 28, 2023

Study information

• Verified date: March 2023
• Source: Hôpital Universitaire Sahloul
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Influenza -Like Illness

Intervention

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

Locations

Country	Name	City	State
Tunisia	CHU sahloul	Sousse

Sponsors (1)

Lead Sponsor	Collaborator
Hôpital Universitaire Sahloul

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality rate	death rate	30 days after inclusion
Primary	need for ICU admission	Number of participants admitted to the intensive care unit	30 days after inclusion
Primary	combined outcome	death or need for admission to the ICU for COVID-19 related complications	30 days after inclusion
Secondary	Date of disappearance of symptoms present on admission	Date of disappearance of symptoms present on admission	30 days after inclusion
Secondary	appearance of an adverse effect due to the administration of the treatment	appearance of an adverse effect due to the administration of the treatment	30 days after inclusion
Secondary	number of patients developing complications	number of patients developing complications	30 days after inclusion
Secondary	number of participants requiring hospitalization due to COVID- infection	number of participants requiring hospitalization due to COVID- infection	30 days after inclusion
Secondary	number of participants requiring respiratory support or hospitalization	number of participants requiring respiratory support or hospitalization	30 days after inclusion