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NCT Number: NCT04376814

Favipiravir Plus Hydroxychloroquine and Lopinavir/Ritonavir Plus Hydroxychloroquine in COVID-19

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.

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Key information

Conditions

COVID-19 Coronaviridae Infections Coronavirus Infections Favipiravir Hydroxychloroquine Infections Kaletra Lopinavir/Ritonavir Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mohammad Sadegh Bagheri Baghdasht

Tehran, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Favipiravir

Drug

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

Hydroxychloroquine

Drug

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 / Ritonavir

Drug

Patients will be given 200/50 mg of Lopinavir / Ritonavir two times per day for seven days.

Other names: Kaletra

Primary outcomes

  1. Mortality

    Time frame: Up to 28 days

    In-hospital mortality

  2. long of hospitalization

    Time frame: Up to 28 days

    long of hospitalization

  3. Laboratory Treatment Response (Blood cell count)

    Time frame: Up to 28 days

    Laboratory Treatment Response; return of blood cell count to normal

  4. Laboratory Treatment Response (CRP )

    Time frame: Up to 28 days

    Laboratory Treatment Response; return of CRP values to normal

  5. Dyspnea

    Time frame: Up to 28 days

    shortness of breath based on symptoms of Dyspnea and questioning the patient

  6. 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.

  7. Oxygen therapy

    Time frame: Up to 28 days

    Oxygen therapy maximum flow during the day (lit/min)

Sponsors and collaborators

Lead sponsor

Baqiyatallah Medical Sciences University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 6, 2020
Registry last updated
Jun 16, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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