Influenza -Like IllnessPhase 1kela-covNCT05670444
Melatonin, Vitamins and Minerals Supplements for the Treatment of Covid-19 and Covid-like Illness
A Phase 1 study testing kelavit in people with Influenza -Like Illness, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Influenza -Like Illness
- What is being tested?
- kelavit
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 150 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2023to 28 Feb 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged less than 60 years old
- no previous medical history
- consulting the emergency department for covid and covid-like illness
- not hospitalized
Who cannot join
- allergy or severe side effect on the study drugs
- refused to consent
- Pregnant women
Trial locations and contacts
1 site in 1 country.
About this study
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
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
Read the 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
- Conditions
- Influenza -Like Illness
- Being tested
- kelavit
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
kelavitDrug
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: kelavit |
| placebo | Placebo comparator | Patients from the placebo group received three similar pills Receives: Drug: kelavit |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality rate
death rate
Measured: 30 days after inclusion
need for ICU admission
Number of participants admitted to the intensive care unit
Measured: 30 days after inclusion
combined outcome
death or need for admission to the ICU for COVID-19 related complications
Measured: 30 days after inclusion
Secondary outcomes (5)
Date of disappearance of symptoms present on admission
Date of disappearance of symptoms present on admission
Measured: 30 days after inclusion
appearance of an adverse effect due to the administration of the treatment
appearance of an adverse effect due to the administration of the treatment
Measured: 30 days after inclusion
number of patients developing complications
number of patients developing complications
Measured: 30 days after inclusion
number of participants requiring hospitalization due to COVID- infection
number of participants requiring hospitalization due to COVID- infection
Measured: 30 days after inclusion
number of participants requiring respiratory support or hospitalization
number of participants requiring respiratory support or hospitalization
Measured: 30 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2023
- Study start2 Jan 2023
- Primary completion28 Feb 2023
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza -Like IllnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- multicenter, randomized , placebo-controlled trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Universitaire Sahloul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Riadh Boukef, Hôpital Universitaire Sahloul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05670444
- Sponsor's protocol ID
- kelavit
- Acronym
- kela-cov
- Status last verified
- Mar 2023
- First submitted
- 26 Dec 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: in the article publication
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05670444
- Acronym / sponsor ID
- kela-cov / kelavit
- Conditions
- Influenza -Like Illness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Hôpital Universitaire SahloulUniversity, hospital or other
- Study start
- 2 Jan 2023 (actual)
- Primary completion
- 28 Feb 2023 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 4 Jan 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- multicenter, randomized , placebo-controlled trial
| Arm | Type | Receives |
|---|---|---|
| kelavit | Active comparator | Drug: kelavitThe 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 |
| placebo | Placebo comparator | Drug: kelavitPatients from the placebo group received three similar pills |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients aged less than 60 years old
- no previous medical history
- consulting the emergency department for covid and covid-like illness
- not hospitalized
Key exclusion criteria (3 listed)
- allergy or severe side effect on the study drugs
- refused to consent
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| kelavitThe 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 |
Primary outcome
mortality rate
Time frame: 30 days after inclusion
death rate
need for ICU admission
Time frame: 30 days after inclusion
Number of participants admitted to the intensive care unit
combined outcome
Time frame: 30 days after inclusion
death or need for admission to the ICU for COVID-19 related complications
5 secondary outcomes
Date of disappearance of symptoms present on admission
Time frame: 30 days after inclusion
appearance of an adverse effect due to the administration of the treatment
Time frame: 30 days after inclusion
number of patients developing complications
Time frame: 30 days after inclusion
number of participants requiring hospitalization due to COVID- infection
Time frame: 30 days after inclusion
number of participants requiring respiratory support or hospitalization
Time frame: 30 days after inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Individual participant dataSharing planned: No. in the article publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing kelavit in people with Influenza -Like Illness, run by Hôpital Universitaire Sahloul at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality rate (time frame: 30 days after inclusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2023.