Covid19Phase 1NCT04590274
Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
A Phase 1 study testing Hydroxychloroquine, Vitamins and Minerals and Azithromycin in people with Covid19 and SARS (Severe Acute Respiratory Syndrome), run by International Brain Research Foundation.
Trial summary
Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Covid19, SARS (Severe Acute Respiratory Syndrome)
- What is being tested?
- Hydroxychloroquine, Vitamins and Minerals and Azithromycin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2020to Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 1) Patients must have one or more of the following:
- confirmed diagnosis of active SARS-CoV-2 infection, diagnosed with PCR
- continued close contact with an individual with suspected SARS-CoV-2 infection
- at risk for SARS-CoV-2 infection in the opinion of the treating physician or Principal Investigator.
Who cannot join
- 1) Patients must not have any uncontrolled disease such as:
- cardiovascular disease
- hepatic disease
- renal disease
- metabolic disease
- other diseases or insufficiencies
About this study
Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.
- Conditions
- Covid19, SARS (Severe Acute Respiratory Syndrome)
- Being tested
- Hydroxychloroquine, Vitamins and Minerals, Azithromycin
- Medical subject headings
- COVID-19, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hydroxychloroquine
Vitamins and MineralsDietary supplement
elemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin
AzithromycinDrug
Azithromycin
| Study group | Role | What they receive |
|---|---|---|
| Regimen | Experimental | 0-400 mg Hydroxychloroquine 0-500 mg Azithromycin 0-50 mg elemental Zinc 0-3,000 mg Vitamin C 0-5,000 IU Vitamin D3 0-1200 mg N-acetylcysteine 0-600 mg Elderberry 0-600 mg Quercetin Receives: Drug: Hydroxychloroquine; Dietary Supplement: Vitamins and Minerals; Drug: Azithromycin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of individuals who develop COVID-19 symptoms
The investigators will compare what percentage of participants in this study go on to develop COVID-19 symptoms, as compared to individuals not on the medicational regimen in this study.
Measured: 6 months from study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study startNov 2020 (estimated)
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
Why it stopped: Investigative Team no longer interested
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- International Brain Research Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Philip DeFina, PhD, International Brain Research Foundation
- Investigators
- Philip DeFina, PhD, Principal investigator, International Brain Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04590274
- Sponsor's protocol ID
- CTP-HCQ-COVID19
- Status last verified
- Dec 2021
- First submitted
- 7 Oct 2020
- Last updated
- 7 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Hydroxychloroquine for the Treatment & Prevention of Coronavirus Disease 2019 (COVID-19) Caused by Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2)
- ClinicalTrials.gov ID
- NCT04590274
- Acronym / sponsor ID
- CTP-HCQ-COVID19
- Conditions
- Covid19, SARS (Severe Acute Respiratory Syndrome)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Investigative Team no longer interested
- Enrolment
- 0 participants (actual)
- Lead sponsor
- International Brain Research FoundationUniversity, hospital or other
- Study start
- Nov 2020 (estimated)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 19 Oct 2020 (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.
Coronavirus Disease 2019 (COVID-19) (previously called 2019-nCOV acute respiratory disease) is caused by SARS-CoV-2, a positive-sense single-stranded RNA virus of the coronavirus family. The coronaviruses are largely responsible for the common cold, the 2002 SARS outbreak in Guangdong, China, the 2012 MERS outbreak in Saudi Arabia, and the present COVID-19 outbreak that originated in Wuhan, China. Much has been reported by way of systemic injury caused by COVID-19 affecting the cardiovascular, hepatic, nervous systems. These conditions are likely the result of the virus overwhelming the immune system. For these reasons, the investigators wish to conduct this study using existing medications off-label, and over-the-counter supplements to support the immune response, prevent lasting injury, and hasten the recovery from COVID-19.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Regimen | Experimental | Drug: Hydroxychloroquine, Dietary Supplement: Vitamins and Minerals, Drug: Azithromycin0-400 mg Hydroxychloroquine 0-500 mg Azithromycin 0-50 mg elemental Zinc 0-3,000 mg Vitamin C 0-5,000 IU Vitamin D3 0-1200 mg N-acetylcysteine 0-600 mg Elderberry 0-600 mg Quercetin |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- confirmed diagnosis of active SARS-CoV-2 infection, diagnosed with PCR
- continued close contact with an individual with suspected SARS-CoV-2 infection
- at risk for SARS-CoV-2 infection in the opinion of the treating physician or Principal Investigator.
Key exclusion criteria (6 listed)
- cardiovascular disease
- hepatic disease
- renal disease
- metabolic disease
- other diseases or insufficiencies
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 |
|---|---|---|
| HydroxychloroquineHydroxychloroquine | Drug | Regimen |
| Vitamins and Mineralselemental Zinc Vitamin C Vitamin D3 N-acetylcysteine Elderberry Quercetin | Dietary supplement | Regimen |
| AzithromycinAzithromycin | Drug | Regimen |
Primary outcome
Percentage of individuals who develop COVID-19 symptoms
Time frame: 6 months from study start
The investigators will compare what percentage of participants in this study go on to develop COVID-19 symptoms, as compared to individuals not on the medicational regimen in this study.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2021.
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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.
Philip DeFina, PhD principal investigator
International Brain Research Foundation
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Hydroxychloroquine, Vitamins and Minerals and Azithromycin in people with Covid19 and SARS (Severe Acute Respiratory Syndrome), run by International Brain Research Foundation.
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 6 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: withdrawn, as of the sponsor's last update on 7 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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 was withdrawn before enrolling participants, so there are no results.
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?
Percentage of individuals who develop COVID-19 symptoms (time frame: 6 months from study start). 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 7 Dec 2021.