Evaluate the Efficacy and Safety of Oral Hydroxychloroquine, Indomethacin and Zithromax in Subjects With Mild Symptoms of COVID-19 (COVID-19)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04344457 |
Recruitment Status :
Recruiting
First Posted : April 14, 2020
Last Update Posted : July 1, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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
Condition or disease | Intervention/treatment | Phase |
---|---|---|
COVID-19 | Drug: Hydroxychloroquine Drug: Indomethacin Drug: Zithromax Oral Product | Phase 1 Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 80 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Open label, single arm study |
Masking: | None (Open Label) |
Masking Description: | Open Label |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | April 16, 2020 |
Estimated Primary Completion Date : | June 20, 2020 |
Estimated Study Completion Date : | September 30, 2020 |

- Drug: Hydroxychloroquine
200 mg PO BID 7 days
- Drug: Indomethacin
50 mg PO TID 14 Days
- Drug: Zithromax Oral Product
500 mg PO QD 3 Days
- 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
- Time of clinical recovery of fever [ Time Frame: up to 15 days ]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)
- Time of clinical recovery of cough [ Time Frame: up to 28 days ]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
- Safety as determined by changes in QTC intervals measured by ECG [ Time Frame: up to 15 days ]to determine the safety of these therapies in combination
- Safety as determined by presence of side effects [ Time Frame: up to 15 days ]to assess the presence or absence of side effects and whether they are tolerable
- Time to improvement [ Time Frame: up to 28 days ]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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- > 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
- 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.
Exclusion Criteria:
- 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
- Renal failure
- Hepatic failure
- NSAID use

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04344457
Contact: Nicole C Hank, PhD,MCR,MHSM | 4804716132 ext 4804716132 | nhank@prcresearcheducation.com |
United States, Arizona | |
Perseverance Research Center | Recruiting |
Scottsdale, Arizona, United States, 85254 | |
Contact: Brandon McCravey 480-471-6132 info@prcresearchaz.com | |
Contact: Laura Chrisitans 4804716132 lchristians@prcresearcheducation.com | |
United States, Louisiana | |
Covidcraz 19, Llc | Recruiting |
New Orleans, Louisiana, United States, 70124 | |
Contact: Kelly G Burkenstock, MD 985-778-9116 kgbmd@hotmail.com |
Principal Investigator: | Teresa Gaither, NP | Athena Medical Group | |
Study Director: | Nicole C. Hank, PhD, MCR, MHSM | Perseverance Research Center |
Responsible Party: | Perseverance Research Center, LLC |
ClinicalTrials.gov Identifier: | NCT04344457 |
Other Study ID Numbers: |
HIZ-PRC-COVID-19 |
First Posted: | April 14, 2020 Key Record Dates |
Last Update Posted: | July 1, 2020 |
Last Verified: | June 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Hydroxychloroquine Azithromycin Indomethacin Antimalarials Antiprotozoal Agents Antiparasitic Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antirheumatic Agents Anti-Inflammatory Agents, Non-Steroidal |
Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Inflammatory Agents Gout Suppressants Tocolytic Agents Reproductive Control Agents Cyclooxygenase Inhibitors Anti-Bacterial Agents |