Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19
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| ClinicalTrials.gov Identifier: NCT04376814 |
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Recruitment Status :
Completed
First Posted : May 6, 2020
Last Update Posted : June 16, 2020
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 Favipiravir Kaletra Hydroxychloroquine Lopinavir/Ritonavir | Drug: Favipiravir Drug: Hydroxychloroquine Drug: Lopinavir / Ritonavir | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 40 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | March 29, 2020 |
| Actual Primary Completion Date : | April 5, 2020 |
| Actual Study Completion Date : | May 25, 2020 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Test Group
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.
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Drug: Favipiravir
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 Drug: Hydroxychloroquine 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. |
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Active Comparator: Control Group
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.
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Drug: Hydroxychloroquine
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. Drug: Lopinavir / Ritonavir Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.
Other Name: Kaletra |
- 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)
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| Ages Eligible for Study: | 16 Years to 100 Years (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- 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
Exclusion Criteria:
- Receiving other antiviral medications such as (Kaletra, Ribavirin, Oseltamivir)
- Chronic liver or renal failure
- HIV; GI bleeding
- Pregnancy
- Lactation
- QT interval > 500 ms.
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): NCT04376814
| Iran, Islamic Republic of | |
| Mohammad Sadegh Bagheri Baghdasht | |
| Tehran, Iran, Islamic Republic of, 0 | |
| Responsible Party: | Mohammad Sadegh Bagheri Baghdasht, Principal Investigator, Baqiyatallah Medical Sciences University |
| ClinicalTrials.gov Identifier: | NCT04376814 |
| Other Study ID Numbers: |
IR.BMSU.REC.1399.017 |
| First Posted: | May 6, 2020 Key Record Dates |
| Last Update Posted: | June 16, 2020 |
| Last Verified: | May 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Ritonavir Lopinavir Hydroxychloroquine |
Favipiravir HIV Protease Inhibitors Viral Protease Inhibitors Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Anti-HIV Agents Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Cytochrome P-450 CYP3A Inhibitors Cytochrome P-450 Enzyme Inhibitors Antimalarials Antiprotozoal Agents Antiparasitic Agents |