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Completed

NCT Number: NCT05670444

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

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

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CHU sahloul

Sousse, Tunisia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

kelavit

Drug

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

Primary outcomes

  1. mortality rate

    Time frame: 30 days after inclusion

    death rate

  2. need for ICU admission

    Time frame: 30 days after inclusion

    Number of participants admitted to the intensive care unit

  3. combined outcome

    Time frame: 30 days after inclusion

    death or need for admission to the ICU for COVID-19 related complications

Secondary outcomes

  1. Date of disappearance of symptoms present on admission

    Time frame: 30 days after inclusion

    Date of disappearance of symptoms present on admission

  2. appearance of an adverse effect due to the administration of the treatment

    Time frame: 30 days after inclusion

    appearance of an adverse effect due to the administration of the treatment

  3. number of patients developing complications

    Time frame: 30 days after inclusion

    number of patients developing complications

  4. number of participants requiring hospitalization due to COVID- infection

    Time frame: 30 days after inclusion

    number of participants requiring hospitalization due to COVID- infection

  5. number of participants requiring respiratory support or hospitalization

    Time frame: 30 days after inclusion

    number of participants requiring respiratory support or hospitalization

Sponsors and collaborators

Lead sponsor

Hôpital Universitaire Sahloul

Other

Registry information

Official study 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

Acronym: kela-cov

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 4, 2023
Registry last updated
Mar 29, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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