COVID-19NCT04376814
Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19
A study testing Favipiravir, Hydroxychloroquine and Lopinavir / Ritonavir in people with COVID-19 and Favipiravir, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
Trial summary
This is an open-label, non-randomized clinical trial study. The number of 40 COVID-19 patients with moderate severity will be admitted in progressive care units (PCUs) and intensive care units (ICUs) enrolled in the study. Read more about this study
- Who is it for?
- Ages 16 to 100 years
- Conditions the study is for
- COVID-19, Favipiravir, Kaletra
- What is being tested?
- Favipiravir, Hydroxychloroquine and Lopinavir / Ritonavir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIran
- Study dates
- 29 Mar 2020to 25 May 2020
- Phase
- Interventional
- 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 16 to 100 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
- Requiring hospitalization
- Patient's age between 16 and 100 years
- Signed informed consent form
Who cannot join
- Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir)
- Chronic liver or renal failure
- HIV; GI bleeding
- Pregnancy
- Lactation
- QT interval > 500 ms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Regimen of Favipiravir Plus Hydroxychloroquine Can Accelerate Recovery of the COVID-19 Patients With Moderate Severity in Comparison to Lopinavir/Ritonavir Plus Hydroxychloroquine Regimen: an Open-label, Non-randomized Clinical Trial Study
This is an open-label, non-randomized clinical trial study. The number of 40 COVID-19 patients with moderate severity will be admitted in progressive care units (PCUs) and intensive care units (ICUs) enrolled in the study. The sampling will be purposive and based on the same independent variables, including age, gender, past medical histories, and the situation of the patient at the admission day, and ventilator support. The patients will be allocated into two groups with different regimens. Group "A" (regimen A)will be defined as Favipiravir 1600 mg a first dose and 600 mg in 3 divided doses daily plus 400 mg in 2 divided doses of Hydroxychloroquine every day. The group "B" (regimen B) will be contained 400 mg of Lopinavir/Ritonavirin 2 divided doses plus the first dose (400 mg) of Hydroxychloroquine. Hydroxychloroquine will not be used for adverse drug reactions. The regimen remained at least 7 up to 10 days.
Data will be analyzed using statistical package for social sciences (SPSS) version 18 (SPSS Inc. Chicago, IL, USA) for windows. The variables will be compared using independent and paired T-test for normally distributed variables and Wilcoxon, Chi-square for non-normal distributed variables. The Kaplan Meier test will be used for survival analysis and the one-sample Kolmogorov-Smirnov test for the evaluation of distributions.
- Conditions
- COVID-19, Favipiravir, Kaletra, Hydroxychloroquine, Lopinavir/Ritonavir
- Being tested
- Favipiravir, Hydroxychloroquine, Lopinavir / Ritonavir
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FavipiravirDrug
Patients will be given a stat dose of 1600mg Favipiravir tablets for the first time, and for next time they will be given 600mg of favipiravir tablets three times per day for 7 days
200mg of Hydroxychloroquine two times per day will be given to patients for seven days in Test group, and Patients in Control group will be given a stat dose of 400mg Hydroxychloroquine tablets two times per day.
Lopinavir / RitonavirDrug
Also called Kaletra
Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | In this group, Patients will be given a stat dose of 1600mg Favipiravir tablets for the first time, and for next time they will be given 600mg of favipiravir tablets three times per day for 7 days, plus 200mg of Hydroxychloroquine two times per day will be given to patients for 7 days. Receives: Drug: Favipiravir; Drug: Hydroxychloroquine |
| Control Group | Active comparator | In this group, Patients will be given a stat dose of 400mg Hydroxychloroquine tablets plus 200/50 mg of Lopinavir/Ritonavirtwo times per day for seven days. Receives: Drug: Hydroxychloroquine; Drug: Lopinavir / Ritonavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
In-hospital mortality
Measured: Up to 28 days
long of hospitalization
long of hospitalization
Measured: Up to 28 days
Laboratory Treatment Response (Blood cell count)
Laboratory Treatment Response; return of blood cell count to normal
Measured: Up to 28 days
Laboratory Treatment Response (CRP )
Laboratory Treatment Response; return of CRP values to normal
Measured: Up to 28 days
Dyspnea
shortness of breath based on symptoms of Dyspnea and questioning the patient
Measured: Up to 28 days
Oxygen saturation without supplemental oxygen.
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Measured: Up to 28 days
Oxygen therapy
Oxygen therapy maximum flow during the day (lit/min)
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 posted6 May 2020
- Study start29 Mar 2020
- Primary completion5 Apr 2020
- Study completion25 May 2020
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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baqiyatallah Medical Sciences University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04376814
- Sponsor's protocol ID
- IR.BMSU.REC.1399.017
- Status last verified
- May 2020
- First submitted
- 3 May 2020
- Last updated
- 16 Jun 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Regimen of Favipiravir Plus Hydroxychloroquine Can Accelerate Recovery of the COVID-19 Patients With Moderate Severity in Comparison to Lopinavir/Ritonavir Plus Hydroxychloroquine Regimen: an Open-label, Non-randomized Clinical Trial Study
- ClinicalTrials.gov ID
- NCT04376814
- Acronym / sponsor ID
- IR.BMSU.REC.1399.017
- Conditions
- COVID-19, Favipiravir, Kaletra, Hydroxychloroquine, Lopinavir/Ritonavir
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Baqiyatallah Medical Sciences UniversityUniversity, hospital or other
- Study start
- 29 Mar 2020 (actual)
- Primary completion
- 5 Apr 2020 (actual)
- Study completion
- 25 May 2020 (actual)
- First posted
- 6 May 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 an open-label, non-randomized clinical trial study. The number of 40 COVID-19 patients with moderate severity will be admitted in progressive care units (PCUs) and intensive care units (ICUs) enrolled in the study. The sampling will be purposive and based on the same independent variables, including age, gender, past medical histories, and the situation of the patient at the admission day, and ventilator support. The patients will be allocated into two groups with different regimens. Group "A" (regimen A)will be defined as Favipiravir 1600 mg a first dose and 600 mg in 3 divided doses daily plus 400 mg in 2 divided doses of Hydroxychloroquine every day. The group "B" (regimen B) will be contained 400 mg of Lopinavir/Ritonavirin 2 divided doses plus the first dose (400 mg) of Hydroxychloroquine. Hydroxychloroquine will not be used for adverse drug reactions. The regimen remained at least 7 up to 10 days.
Data will be analyzed using statistical package for social sciences (SPSS) version 18 (SPSS Inc. Chicago, IL, USA) for windows. The variables will be compared using independent and paired T-test for normally distributed variables and Wilcoxon, Chi-square for non-normal distributed variables. The Kaplan Meier test will be used for survival analysis and the one-sample Kolmogorov-Smirnov test for the evaluation of distributions.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Drug: Favipiravir, Drug: HydroxychloroquineIn this group, Patients will be given a stat dose of 1600mg Favipiravir tablets for the first time, and for next time they will be given 600mg of favipiravir tablets three times per day for 7 days, plus 200mg of Hydroxychloroquine two times per day will be given to patients for 7 days. |
| Control Group | Active comparator | Drug: Hydroxychloroquine, Drug: Lopinavir / RitonavirIn this group, Patients will be given a stat dose of 400mg Hydroxychloroquine tablets plus 200/50 mg of Lopinavir/Ritonavirtwo times per day for seven days. |
Who may qualify
- Ages
- 16 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RT-PCR test for COVID-19
- Requiring hospitalization
- Patient's age between 16 and 100 years
- Signed informed consent form
Key exclusion criteria (6 listed)
- Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir)
- Chronic liver or renal failure
- HIV; GI bleeding
- Pregnancy
- Lactation
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 |
|---|---|---|
| FavipiravirPatients will be given a stat dose of 1600mg Favipiravir tablets for the first time, and for next time they will be given 600mg of favipiravir tablets three times per day for 7 days | Drug | Test Group |
| Hydroxychloroquine200mg of Hydroxychloroquine two times per day will be given to patients for seven days in Test group, and Patients in Control group will be given a stat dose of 400mg Hydroxychloroquine tablets two times per day. | Drug | Control Group, Test Group |
| Lopinavir / RitonavirAlso: KaletraPatients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days. | Drug | Control Group |
Primary outcome
Mortality
Time frame: Up to 28 days
In-hospital mortality
long of hospitalization
Time frame: Up to 28 days
long of hospitalization
Laboratory Treatment Response (Blood cell count)
Time frame: Up to 28 days
Laboratory Treatment Response; return of blood cell count to normal
Laboratory Treatment Response (CRP )
Time frame: Up to 28 days
Laboratory Treatment Response; return of CRP values to normal
Dyspnea
Time frame: Up to 28 days
shortness of breath based on symptoms of Dyspnea and questioning the patient
Oxygen saturation without supplemental oxygen.
Time frame: Up to 28 days
Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes.
Oxygen therapy
Time frame: Up to 28 days
Oxygen therapy maximum flow during the day (lit/min)
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 16 Jun 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Favipiravir, Hydroxychloroquine and Lopinavir / Ritonavir in people with COVID-19 and Favipiravir, run by Baqiyatallah Medical Sciences University at 1 site in Iran.
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: finished, as of the sponsor's last update on 16 Jun 2020. 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 Iran. 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.
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?
Mortality (time frame: Up to 28 days). 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?
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 16 Jun 2020.