Melatonin, Vitamins and Minerals Supplements for the Treatment of Covid-19 and Covid-like Illness
Condition: Influenza -Like Illness
Study type: Interventional
Phase: Phase 1

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
    

Intervention name(s): kelavit
Intervention type(s): Drug
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: multicenter, randomized , placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment