Clinical trial NCT05670444: Melatonin, Vitamins and Minerals Supplements for the Treatment of Covid-19 and Covid-like Illness
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Influenza -Like Illness
Lead sponsor: Hôpital Universitaire Sahloul
Sponsor class: OTHER
First posted: 2023-01-04
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicenter, randomized , placebo-controlled trial
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: mortality rate
timeFrame: 30 days after inclusion
measure: need for ICU admission
timeFrame: 30 days after inclusion
measure: combined outcome
timeFrame: 30 days after inclusion
Secondary outcomes:
measure: Date of disappearance of symptoms present on admission
timeFrame: 30 days after inclusion
measure: appearance of an adverse effect due to the administration of the treatment
timeFrame: 30 days after inclusion
measure: number of patients developing complications
timeFrame: 30 days after inclusion
measure: number of participants requiring hospitalization due to COVID- infection
timeFrame: 30 days after inclusion
measure: number of participants requiring respiratory support or hospitalization
timeFrame: 30 days after inclusion
Other outcomes:
Locations:
city: Sousse
country: Tunisia
facility: CHU sahloul
Study officials:
References: