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

NCT05670444 | Completed Phase 1

• 1 other identifier: kelavit
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Conditions

Influenza -Like Illness

Outcome Measures

Primary Outcomes (3)

• mortality rate

  death rate

  30 days after inclusion

• need for ICU admission

  Number of participants admitted to the intensive care unit

  30 days after inclusion

• combined outcome

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

  30 days after inclusion

Secondary Outcomes (5)

• Date of disappearance of symptoms present on admission

  30 days after inclusion

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

  30 days after inclusion

• number of patients developing complications

  30 days after inclusion

• number of participants requiring hospitalization due to COVID- infection

  30 days after inclusion

• number of participants requiring respiratory support or hospitalization

  30 days after inclusion

Study Arms (2)

kelavit

ACTIVE COMPARATOR

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

placebo

PLACEBO COMPARATOR

Patients from the placebo group received three similar pills

Drug: kelavit

Interventions

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

kelavit; placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients aged less than 60 years old
• no previous medical history
• consulting the emergency department for covid and covid-like illness
• not hospitalized

You may not qualify if:

• allergy or severe side effect on the study drugs
• refused to consent
• Pregnant women

Sponsors & Collaborators

• Hôpital Universitaire Sahloul: lead

Study Sites (1)

CHU sahloul

Sousse, Tunisia

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: chef of emergency departement

Model Details: multicenter, randomized , placebo-controlled trial

Study Record Dates

• First Submitted: December 26, 2022
• First Posted: January 4, 2023
• Study Start: January 2, 2023
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)