Clinical trial NCT04376814: Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: COVID-19
Favipiravir
Kaletra
Hydroxychloroquine
Lopinavir/Ritonavir
Lead sponsor: Baqiyatallah Medical Sciences University
Sponsor class: OTHER
First posted: 2020-05-06
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 100
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Mortality
timeFrame: Up to 28 days
measure: long of hospitalization
timeFrame: Up to 28 days
measure: Laboratory Treatment Response (Blood cell count)
timeFrame: Up to 28 days
measure: Laboratory Treatment Response (CRP )
timeFrame: Up to 28 days
measure: Dyspnea
timeFrame: Up to 28 days
measure: Oxygen saturation without supplemental oxygen.
timeFrame: Up to 28 days
measure: Oxygen therapy
timeFrame: Up to 28 days
Secondary outcomes:
Other outcomes:
Locations:
city: Tehran
country: Iran, Islamic Republic of
facility: Mohammad Sadegh Bagheri Baghdasht
Study officials:
References: