COVIDPhase 1NCT04482686
Trial of Combination Therapy to Treat COVID-19 Infection
A Phase 1 study testing Ivermectin, Doxycycline Hcl and Zinc in people with COVID and Covid-19, run by ProgenaBiome at 1 site in United States.
Trial summary
In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Covid-19, Corona Virus Infection
- What is being tested?
- Ivermectin, Doxycycline Hcl and Zinc
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Dec 2020to 15 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
- Healthy male or female subjects at least 18 years of age
- Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization will be stratified.
- Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
- Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. One of these must be a barrier method. Exceptions for females and partners of females that are not of childbearing potential. (e.g. surgically sterilized, post-menopausal)
- Subjects must agree they will attend the treatment facility daily for 10d in the event of failure to attend, the patient will be visited at their home to collect the nasal swab and review data.
Who cannot join
- Refusal to sign informed consent form
- Negative test for COVID-19 by RT-PCR at screening
- Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 104.0 degrees F, pleuritic pain, or frequent cough.
- Known drug allergy to any of the investigational medications
- Currently taking medication with known drug interactions with investigational medications, found in Appendix II
- Prescription or other antiviral medications
- Any comorbidities which constitute health risk for the subject including known cardiac arrhythmias - but will be limited to those on hydroxychloroquine
- Inability to attend daily for 10 days
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection
In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Read the detailed description
Patients in this trial will undergo treatment for 10 days with either a combination of therapies or placebo. They will then be followed for an additional 20 days.
- Conditions
- COVID, Covid-19, Corona Virus Infection, Coronavirus Infection, Coronavirus-19, SARS-CoV2
- Being tested
- Ivermectin, Doxycycline Hcl, Zinc, Vitamin D3, Vitamin C
- Medical subject headings
- COVID-19, Coronavirus Infections, Severe Acute Respiratory Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IvermectinDrug
Also called Soolantra, Stromectol, Sklice
Treatment days 1, 4, and 8
Doxycycline HclDrug
Also called Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory
10 day treatment
ZincDietary supplement
Also called Zinc sulphate
10 Day treatment
Vitamin D3Dietary supplement
Also called cholecalciferol-D3
10 day treatment
Vitamin CDietary supplement
Also called L-ascorbic acid
10 day treatment
| Study group | Role | What they receive |
|---|---|---|
| Active Arm | Experimental | Patients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C Receives: Drug: Ivermectin; Drug: Doxycycline Hcl; Dietary Supplement: Zinc; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin C |
| Placebo | Placebo comparator | Placebo and Vitamin D3, Vitamin C, and Zinc Receives: Dietary Supplement: Zinc; Dietary Supplement: Vitamin D3; Dietary Supplement: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Non-Infectivity by RT-PCR
Time to negative RT-PRC result indicating that patient is no longer infective
Measured: 6 months
Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measured: 6 months
Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Measured: 6 months
Efficacy of Treatment as measured by Titer
Patients will have serum stored for titer testing to compare antibody levels over time
Measured: 6 months
Efficacy of Treatment as measured by RT-PCR
Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
Measured: 10 days
Secondary outcomes (8)
Safety of Treatment as Measured by D-Dimer
Blood D-Dimer levels
Measured: 6 Months
Safety of Treatment as Measured by Pro-Calcitonin
Blood Pro-Calcitonin levels
Measured: 6 Months
Safety of Treatment as Measured by C-Reactive Protein
Blood CRP levels
Measured: 6 Months
Safety of Treatment as Measured by Ferritin
Blood ferritin levels
Measured: 6 Months
Safety of Treatment as Measured by Liver Enzymes
Blood enzyme levels
Measured: 6 Months
Safety of Treatment as Measured by Complete Blood Count
CBC
Measured: 6 Months
Safety of Treatment as Measured by Electrolyte Levels
Blood electrolytes
Measured: 6 Months
Safety of Treatment as Measured by Treatment Related Adverse Events
Presence or absence of Grade 3 or high treatment related adverse events
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start9 Dec 2020
- Primary completion15 May 2022
- Study completion15 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVIDStudies 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- ProgenaBiome
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sabine Hazan, MD, Study director, ProgenaBiomeThomas Borody, MD, Study director, Topelia Therpeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04482686
- Sponsor's protocol ID
- PRG-049
- Status last verified
- Sep 2024
- First submitted
- 21 Jul 2020
- Last updated
- 24 Sep 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hazan S, Vidal AC, Hulscher N, Goudzwaard A, McCullough PA, Steinberg AA. Cardiac findings in a phase II double-blind randomized placebo-controlled trial of combination therapy (HAZDPac) to treat COVID-19 patients. BMC Cardiovasc Disord. 2024 Dec 19;24(1):710. doi: 10.1186/s12872-024-04376-y.
PubMed 39702045Hazan S, Dave S, Gunaratne AW, Dolai S, Clancy RL, McCullough PA, Borody TJ. Effectiveness of ivermectin-based multidrug therapy in severely hypoxic, ambulatory COVID-19 patients. Future Microbiol. 2022 Mar;17:339-350. doi: 10.2217/fmb-2022-0014. Epub 2022 Feb 9.
PubMed 35135310
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Double-Blind Randomized Placebo-Controlled Trial of Combination Therapy to Treat COVID-19 Infection
- ClinicalTrials.gov ID
- NCT04482686
- Acronym / sponsor ID
- PRG-049
- Conditions
- COVID, Covid-19, Corona Virus Infection, Coronavirus Infection, Coronavirus-19, SARS-CoV2
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- ProgenaBiomeUniversity, hospital or other
- Study start
- 9 Dec 2020 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 Jul 2022 (actual)
- First posted
- 22 Jul 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.
In this trial patients will be treated with either a combination of therapies to treat COVID-19 or a placebo. Treatment will last 10 days, and patients will be followed for 6 months.
Detailed description
Patients in this trial will undergo treatment for 10 days with either a combination of therapies or placebo. They will then be followed for an additional 20 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active Arm | Experimental | Drug: Ivermectin, Drug: Doxycycline Hcl, Dietary Supplement: Zinc, Dietary Supplement: Vitamin D3, Dietary Supplement: Vitamin CPatients will be treated with a combination of Ivermectin, Doxycycline, Zinc, Vitamin D3 and Vitamin C |
| Placebo | Placebo comparator | Dietary Supplement: Zinc, Dietary Supplement: Vitamin D3, Dietary Supplement: Vitamin CPlacebo and Vitamin D3, Vitamin C, and Zinc |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent, demonstrating that the subject understands the procedures required for the study and the purpose of the study
- Healthy male or female subjects at least 18 years of age
- Diabetic and obese (BMI > 30) patients will be included in the Trial but randomization will be stratified.
- Positive test for COVID-19 by RT-PCR or rapid antigen test at screening
- Subjects must agree to practice at least two highly effective methods of birth control for the duration of the study. One of these must be a barrier method. Exceptions for females and partners of females that are not of childbearing potential. (e.g. surgically sterilized, post-menopausal)
Key exclusion criteria (8 listed)
- Refusal to sign informed consent form
- Negative test for COVID-19 by RT-PCR at screening
- Severe disease symptomatically including pneumonia, respiratory distress, tachypnea, shortness of breath, temperature > 104.0 degrees F, pleuritic pain, or frequent cough.
- Known drug allergy to any of the investigational medications
- Currently taking medication with known drug interactions with investigational medications, found in Appendix II
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 |
|---|---|---|
| IvermectinAlso: Soolantra, Stromectol, SkliceTreatment days 1, 4, and 8 | Drug | Active Arm |
| Doxycycline HclAlso: Doxy-100, Monodox, Oracea, Targadox, Acticlate, Morgidox, Avidoxy, Doryx MPC, Mondoxyne NL, Dory10 day treatment | Drug | Active Arm |
| ZincAlso: Zinc sulphate10 Day treatment | Dietary supplement | Active Arm, Placebo |
| Vitamin D3Also: cholecalciferol-D310 day treatment | Dietary supplement | Active Arm, Placebo |
| Vitamin CAlso: L-ascorbic acid10 day treatment | Dietary supplement | Active Arm, Placebo |
Primary outcome
Time to Non-Infectivity by RT-PCR
Time frame: 6 months
Time to negative RT-PRC result indicating that patient is no longer infective
Time to Symptom progression in days as measured by NEWS scoring system (National Early Warning Score)
Time frame: 6 months
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Time to Symptom improvement as measured by NEWS scoring system (National Early Warning Score)
Time frame: 6 months
Time to reduced symptoms in each treatment group as indicated by NEWS scores, which rate patient status based on a zero to three scale for 8 parameters. These values are added up to create the NEWS score. The lower the NEWS score, the better the patient's clinical condition. Zero is the lowest possible score, whereas 7 or greater represents a high degree of clinical risk.
Efficacy of Treatment as measured by Titer
Time frame: 6 months
Patients will have serum stored for titer testing to compare antibody levels over time
Efficacy of Treatment as measured by RT-PCR
Time frame: 10 days
Number of patients testing negative for SARS-CoV-2 by RT-PCR after 10 days of treatment
8 secondary outcomes
Safety of Treatment as Measured by D-Dimer
Time frame: 6 Months
Safety of Treatment as Measured by Pro-Calcitonin
Time frame: 6 Months
Safety of Treatment as Measured by C-Reactive Protein
Time frame: 6 Months
Safety of Treatment as Measured by Ferritin
Time frame: 6 Months
Safety of Treatment as Measured by Liver Enzymes
Time frame: 6 Months
Safety of Treatment as Measured by Complete Blood Count
Time frame: 6 Months
Safety of Treatment as Measured by Electrolyte Levels
Time frame: 6 Months
Safety of Treatment as Measured by Treatment Related Adverse Events
Time frame: 6 months
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 24 Sep 2024.
- Derived from this study: PubMed 39702045Hazan S, Vidal AC, Hulscher N, Goudzwaard A, McCullough PA, Steinberg AA. Cardiac findings in a phase II double-blind randomized placebo-controlled trial of combination therapy (HAZDPac) to treat COVID-19 patients. BMC Cardiovasc Disord. 2024 Dec 19;24(1):710. doi: 10.1186/s12872-024-04376-y.
- Derived from this study: PubMed 35135310Hazan S, Dave S, Gunaratne AW, Dolai S, Clancy RL, McCullough PA, Borody TJ. Effectiveness of ivermectin-based multidrug therapy in severely hypoxic, ambulatory COVID-19 patients. Future Microbiol. 2022 Mar;17:339-350. doi: 10.2217/fmb-2022-0014. Epub 2022 Feb 9.
- 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 study director
ProgenaBiome
Thomas Borody, MD study director
Topelia Therpeutics
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 Ivermectin, Doxycycline Hcl and Zinc in people with COVID and Covid-19, 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 6 inclusion and 8 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 24 Sep 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 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?
Time to Non-Infectivity by RT-PCR (time frame: 6 months). The study lists 5 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 NCT04482686, which also lists 2 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 24 Sep 2024.