COVID-19Phase 1/2COVID-19NCT04344457
Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19
A Phase 1/2 study testing Hydroxychloroquine, Indomethacin and Zithromax Oral Product in people with COVID-19, run by Perseverance Research Center, LLC at 2 sites in United States.
Trial summary
Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Hydroxychloroquine, Indomethacin and Zithromax Oral Product
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 2 sitesUnited States
- Study dates
- 16 Apr 2020to 30 Sep 2020
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- > 18 years of age
- Willing and able to provide written informed consent prior to performing study procedures
- Confirmed Sars-CoV2 infection by PCR
- Have mild symptoms of Sars-CoV2
- Must show documentation of Sars-CoV2 to screening visit
- Must have had recent hematology and chemistry results
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- Must be able to take heart rate daily
- Must agree to Skype/Facetime daily
- Must agree to take temperature daily
- Must agree not to enroll in another study of an investigational agent prior to completion of Day 14 of treatment.
Who cannot join
- Known to be allergic to research drugs or drug excipients
- Incapable of providing informed consent
- Participation in any other clinical trial of an experimental treatment for Sars-CoV2 infection
- Pregnancy, possible pregnancy or breast feeding
- Prolonged QT interval (>450)
- Moderate to severe symptoms of Sars-CoV2
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- Renal failure
- Hepatic failure
- NSAID use
Trial locations and contacts
2 sites in 1 country.
United States2 sites, 2 recruiting
- Recruiting
Covidcraz 19, Llc
New Orleans, Louisiana, 70124
Kelly G Burkenstock, MD, 985-778-9116, kgbmd@hotmail.com
- Recruiting
Perseverance Research Center
Scottsdale, Arizona, 85254
Brandon McCravey, 480-471-6132, info@prcresearchaz.com
Laura Chrisitans, 4804716132, lchristians@prcresearcheducation.com
About this study
Official title: An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects Positive With SARS-CoV-2 With Mild Symptoms
Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe; however, currently there are no clinical trials available to patients in Arizona.
This study will determine if a specific drug cocktail can improve clinical outcomes in patients with confirmed Mild SARS-CoV-2
Read the detailed description
COVID-19 has become a massive threat to public health worldwide. Current estimates suggest that the novel coronavirus (SARS-CoV-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%); therefore, interventions to decrease the incidence and severity of COVID-19 are emergently needed. In Maricopa County there has yet to be a clinical trial to evaluate people who are SARS-CoV-2 positive with mild symptoms. This study will measure the improvement of COVID-19 disease status as measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free on 14 days of a cocktail therapy of Hydroxychloroquine, Indomethacin and Zithromax.
- Conditions
- COVID-19
- Being tested
- Hydroxychloroquine, Indomethacin, Zithromax Oral Product
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
200 mg PO BID 7 days
IndomethacinDrug
50 mg PO TID 14 Days
Zithromax Oral ProductDrug
500 mg PO QD 3 Days
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of clinical status
measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free
Measured: up to 28 days
Secondary outcomes (5)
Time of clinical recovery of fever
the time of normalization of fever as measured by daily temperature ( - ≤36.6°C or -axilla, ≤37.2 °C oral or ≤37.8°C rectal or tympanic)
Measured: up to 15 days
Time of clinical recovery of cough
the time of alleviation of cough as measured by self reported visual analog scale (VAS) cough scale. 1=no cough, 2-3=cough sometimes, 4-6=have a cough but can still do things, 7-8=persistent cough, prevents from doing things, 9-10=cough presents a great deal of discomfort
Measured: up to 28 days
Safety as determined by changes in QTC intervals measured by ECG
to determine the safety of these therapies in combination
Measured: up to 15 days
Safety as determined by presence of side effects
to assess the presence or absence of side effects and whether they are tolerable
Measured: up to 15 days
Time to improvement
improvement in Wisconsin Upper Respiratory Symptom Survey (WURSS-44) 0 to 7 scale, with 0 = Do not have, 1 = Very mild, 3 = Mild, 5 = Moderate, 7 = Severe
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start16 Apr 2020
- Primary completion20 Jun 2020 (estimated)
- Study completion30 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Open label, single arm study
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perseverance Research Center, LLC
- Sponsor type
- University, hospital or other
- Collaborators
- Athena Medical Group
- Responsible party
- Sponsor
- Investigators
- Teresa Gaither, NP, Principal investigator, Athena Medical GroupNicole C. Hank, PhD, MCR, MHSM, Study director, Perseverance Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344457
- Sponsor's protocol ID
- HIZ-PRC-COVID-19
- Acronym
- COVID-19
- Status last verified
- Jun 2020
- First submitted
- 8 Apr 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Single-Arm, Phase II Study to Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects Positive With SARS-CoV-2 With Mild Symptoms
- ClinicalTrials.gov ID
- NCT04344457
- Acronym / sponsor ID
- COVID-19 / HIZ-PRC-COVID-19
- Conditions
- COVID-19
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Perseverance Research Center, LLCUniversity, hospital or other
- Collaborators
- Athena Medical Group
- Study start
- 16 Apr 2020 (actual)
- Primary completion
- 20 Jun 2020 (estimated)
- Study completion
- 30 Sep 2020 (estimated)
- First posted
- 14 Apr 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.
Currently there are no US Food and Drug Administration (FDA)-approved drugs specifically for the treatment of patients with COVID-19. At present, clinical management includes infection prevention and control measures, as well as supportive care, including supplementary oxygen and mechanical ventilatory support when indicated. An array of drugs approved for other indications as well as several investigational drugs are being studied in several hundred clinical trials that are underway across the globe; however, currently there are no clinical trials available to patients in Arizona.
This study will determine if a specific drug cocktail can improve clinical outcomes in patients with confirmed Mild SARS-CoV-2
Detailed description
COVID-19 has become a massive threat to public health worldwide. Current estimates suggest that the novel coronavirus (SARS-CoV-2) is both highly contagious (estimated reproductive rate, 2-3) and five to fifty-fold more lethal than seasonal influenza (estimated mortality rate, 0.5-5%); therefore, interventions to decrease the incidence and severity of COVID-19 are emergently needed. In Maricopa County there has yet to be a clinical trial to evaluate people who are SARS-CoV-2 positive with mild symptoms. This study will measure the improvement of COVID-19 disease status as measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free on 14 days of a cocktail therapy of Hydroxychloroquine, Indomethacin and Zithromax.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Model description
- Open label, single arm study
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- > 18 years of age
- Willing and able to provide written informed consent prior to performing study procedures
- Confirmed Sars-CoV2 infection by PCR
- Have mild symptoms of Sars-CoV2
- Must show documentation of Sars-CoV2 to screening visit
Key exclusion criteria (9 listed)
- Known to be allergic to research drugs or drug excipients
- Incapable of providing informed consent
- Participation in any other clinical trial of an experimental treatment for Sars-CoV2 infection
- Pregnancy, possible pregnancy or breast feeding
- Prolonged QT interval (>450)
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 |
|---|---|---|
| Hydroxychloroquine200 mg PO BID 7 days | Drug | – |
| Indomethacin50 mg PO TID 14 Days | Drug | – |
| Zithromax Oral Product500 mg PO QD 3 Days | Drug | – |
Primary outcome
Improvement of clinical status
Time frame: up to 28 days
measured by time (days) required from initiation of treatment to improvement of clinical status from mild to symptom free
5 secondary outcomes
Time of clinical recovery of fever
Time frame: up to 15 days
Time of clinical recovery of cough
Time frame: up to 28 days
Safety as determined by changes in QTC intervals measured by ECG
Time frame: up to 15 days
Safety as determined by presence of side effects
Time frame: up to 15 days
Time to improvement
Time frame: up to 28 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Teresa Gaither, NP principal investigator
Athena Medical Group
Nicole C. Hank, PhD, MCR, MHSM study director
Perseverance Research Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Hydroxychloroquine, Indomethacin and Zithromax Oral Product in people with COVID-19, run by Perseverance Research Center, LLC at 2 sites in United States.
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 10 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nicole C Hank, PhD,MCR,MHSM (4804716132 ext. 4804716132, nhank@prcresearcheducation.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement of clinical status (time frame: up to 28 days). 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 1 Jul 2020.