COVID-19Phase 2HAZDpaCNCT04334512
A Study of Quintuple Therapy to Treat COVID-19 Infection
A Phase 2 study testing Hydroxychloroquine, Azithromycin and Vitamin C in people with COVID-19 and Corona Virus Infection, run by ProgenaBiome at 1 site in United States.
Trial summary
This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Corona Virus Infection, Coronavirus-19
- What is being tested?
- Hydroxychloroquine, Azithromycin and Vitamin C
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 118 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Jun 2020to 27 Feb 2024
- Phase
- Phase 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
None listed.
Who cannot join
- Refusal to provide informed consent
- Diarrhea prior to infection
- Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject
- Any contraindications for treatment with hydroxychloroquine
- Hypoglycemia
- Known G6PD deficiency
Show all 24Show fewer
- Porphyria
- Anemia
- Neutropenia
- Alcoholism
- Myasthenia gravis
- Skeletal muscle disorders
- Maculopathy
- Changes in visual field
- Liver disease
- Psoriasis
- Anemia from pyruvate kinase and G6PD deficiencies
- Abnormal EKG with QT prolongation acquired or from birth
- Allergies to 4-Aminoquinolines
- History of jaundice or high fevers prior to developing COVID-19
- Treatment with any of the medications listed in Appendix II
- Treatment with any other drug not listed that affects the QT interval
- Treatment with any anti-epileptic drug, whether prescribed for seizures or otherwise.
- Pregnant or breastfeeding women
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
Read the detailed description
In this study patients will be treated with a combination therapy to determine if this combination can effectively treat COVID-19. Treatment will last ten days. The study will last 24 weeks.
- Conditions
- COVID-19, Corona Virus Infection, Coronavirus-19, Sars-CoV2
- Being tested
- Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, Zinc
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Plaquenil
Treatment with hydroxychloroquine
AzithromycinDrug
Also called Zithromax
Treatment with azithromycin
Vitamin CDietary supplement
Treatment with vitamin C
Vitamin DDietary supplement
Treatment with vitamin D
ZincDietary supplement
Treatment with Zinc
| Study group | Role | What they receive |
|---|---|---|
| Quintuple Therapy | Experimental | Patients will be treated with quintuple therapy for 10 days. Receives: Drug: Hydroxychloroquine; Drug: Azithromycin; Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc |
| Placebo | Placebo comparator | Patients will be treated with placebo. Receives: Dietary Supplement: Vitamin C; Dietary Supplement: Vitamin D; Dietary Supplement: Zinc |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Measured: 12 weeks
Reduction or Progression of Symptomatic Days
Reduction and/or progression of symptomatic days, reduction of symptom severity
Measured: 12 weeks
Assess the safety of Quintuple Therapy
Assess the symptom response to study therapy as measured by the survey in the EDC
Measured: 12 weeks
Assess the safety of Quintuple Therapy via pulse
Pulse from baseline to 12 weeks
Measured: 12 weeks
Assess the safety of Quintuple Therapy via oxygen saturation
Oxygen saturation from baseline to 12 weeks
Measured: 12 weeks
Assess the safety of Quintuple Therapy via EKG
EKG response from baseline to 12 weeks
Measured: 12 weeks
Assess Tolerability of Quintuple Therapy
Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2020
- Study start22 Jun 2020
- Primary completion27 Feb 2024
- Study completion27 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Collaborators
- DSCS CRO
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Principal investigator, ProgenaBiome
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04334512
- Sponsor's protocol ID
- PRG-044
- Acronym
- HAZDpaC
- Status last verified
- Feb 2024
- First submitted
- 2 Apr 2020
- Last updated
- 29 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Banjanac M, Munic Kos V, Nujic K, Vrancic M, Belamaric D, Crnkovic S, Hlevnjak M, Erakovic Haber V. Anti-inflammatory mechanism of action of azithromycin in LPS-stimulated J774A.1 cells. Pharmacol Res. 2012 Oct;66(4):357-62. doi: 10.1016/j.phrs.2012.06.011. Epub 2012 Jul 3.
PubMed 22766077Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10.
PubMed 32173110Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.
PubMed 32074550Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
PubMed 32205204Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.
PubMed 32052466
Study at a glance
From the registry record, last updated by the sponsor on 29 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase IIa Study of Quintuple Therapy to Treat COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04334512
- Acronym / sponsor ID
- HAZDpaC / PRG-044
- Conditions
- COVID-19, Corona Virus Infection, Coronavirus-19, Sars-CoV2
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Collaborators
- DSCS CRO
- Study start
- 22 Jun 2020 (actual)
- Primary completion
- 27 Feb 2024 (actual)
- Study completion
- 27 Feb 2024 (actual)
- First posted
- 6 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.
This is a Phase II interventional study will test the efficacy of quintuple therapy (Hydroxychloroquine, Azithromycin, Vitamin C, Vitamin D, and Zinc) in the treatment of patients with COVID-19 infection).
Detailed description
In this study patients will be treated with a combination therapy to determine if this combination can effectively treat COVID-19. Treatment will last ten days. The study will last 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This is a Randomized, Double-Blind, Placebo-Controlled Phase II interventional Study
| Arm | Type | Receives |
|---|---|---|
| Quintuple Therapy | Experimental | Drug: Hydroxychloroquine, Drug: Azithromycin, Dietary Supplement: Vitamin C, Dietary Supplement: Vitamin D, Dietary Supplement: ZincPatients will be treated with quintuple therapy for 10 days. |
| Placebo | Placebo comparator | Dietary Supplement: Vitamin C, Dietary Supplement: Vitamin D, Dietary Supplement: ZincPatients will be treated with placebo. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (24 listed)
- Refusal to provide informed consent
- Diarrhea prior to infection
- Any comorbidities which, in the opinion of the investigator, constitute health risk for the subject
- Any contraindications for treatment with hydroxychloroquine
- Anemia from pyruvate kinase and G6PD deficiencies
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 |
|---|---|---|
| HydroxychloroquineAlso: PlaquenilTreatment with hydroxychloroquine | Drug | Quintuple Therapy |
| AzithromycinAlso: ZithromaxTreatment with azithromycin | Drug | Quintuple Therapy |
| Vitamin CTreatment with vitamin C | Dietary supplement | Placebo, Quintuple Therapy |
| Vitamin DTreatment with vitamin D | Dietary supplement | Placebo, Quintuple Therapy |
| ZincTreatment with Zinc | Dietary supplement | Placebo, Quintuple Therapy |
Primary outcome
The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy
Time frame: 12 weeks
Number of days from COVID-19 diagnosis to recovery via RT-PCR
Reduction or Progression of Symptomatic Days
Time frame: 12 weeks
Reduction and/or progression of symptomatic days, reduction of symptom severity
Assess the safety of Quintuple Therapy
Time frame: 12 weeks
Assess the symptom response to study therapy as measured by the survey in the EDC
Assess the safety of Quintuple Therapy via pulse
Time frame: 12 weeks
Pulse from baseline to 12 weeks
Assess the safety of Quintuple Therapy via oxygen saturation
Time frame: 12 weeks
Oxygen saturation from baseline to 12 weeks
Assess the safety of Quintuple Therapy via EKG
Time frame: 12 weeks
EKG response from baseline to 12 weeks
Assess Tolerability of Quintuple Therapy
Time frame: 12 weeks
Assess Adverse Events and Serious Adverse Events due to Quintuple Therapy
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 Feb 2024.
- Background: PubMed 22766077Banjanac M, Munic Kos V, Nujic K, Vrancic M, Belamaric D, Crnkovic S, Hlevnjak M, Erakovic Haber V. Anti-inflammatory mechanism of action of azithromycin in LPS-stimulated J774A.1 cells. Pharmacol Res. 2012 Oct;66(4):357-62. doi: 10.1016/j.phrs.2012.06.011. Epub 2012 Jul 3.
- Background: PubMed 32173110Cortegiani A, Ingoglia G, Ippolito M, Giarratano A, Einav S. A systematic review on the efficacy and safety of chloroquine for the treatment of COVID-19. J Crit Care. 2020 Jun;57:279-283. doi: 10.1016/j.jcrc.2020.03.005. Epub 2020 Mar 10.
- Background: PubMed 32074550Gao J, Tian Z, Yang X. Breakthrough: Chloroquine phosphate has shown apparent efficacy in treatment of COVID-19 associated pneumonia in clinical studies. Biosci Trends. 2020 Mar 16;14(1):72-73. doi: 10.5582/bst.2020.01047. Epub 2020 Feb 19.
- Background: PubMed 32205204Gautret P, Lagier JC, Parola P, Hoang VT, Meddeb L, Mailhe M, Doudier B, Courjon J, Giordanengo V, Vieira VE, Tissot Dupont H, Honore S, Colson P, Chabriere E, La Scola B, Rolain JM, Brouqui P, Raoult D. RETRACTED: Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial. Int J Antimicrob Agents. 2020 Jul;56(1):105949. doi: 10.1016/j.ijantimicag.2020.105949. Epub 2020 Mar 20.
- Background: PubMed 32052466Zhang L, Liu Y. Potential interventions for novel coronavirus in China: A systematic review. J Med Virol. 2020 May;92(5):479-490. doi: 10.1002/jmv.25707. Epub 2020 Mar 3.
- 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.
Sabine Hazan, MD principal investigator
ProgenaBiome
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Hydroxychloroquine, Azithromycin and Vitamin C in people with COVID-19 and Corona Virus Infection, run by ProgenaBiome at 1 site 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 0 inclusion and 24 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 Feb 2024. 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 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. 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 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?
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?
The rate of recovery of mild or moderate COVID-19 in patients using Quintuple Therapy (time frame: 12 weeks). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04334512, which also lists 5 linked publications.
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 Feb 2024.