Comparison of Remdesivir Versus Lopinavir/ Ritonavir and Remdesivir Combination in COVID-19 Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-11-01

Study Completion Date

2021-04-01

Brief Summary

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Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received remdesivir alone with patients who received remdesivir in combination with lopinavir/ ritonavir in addition to standard management.

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Detailed Description

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Aim of the study

1. To assess the difference in patients' clinical status improvement between patients receiving remdesivir alone and patients receiving remdesivir and lopinavir/ ritonavir.
2. To detect time to improvement in oxygenation among both groups.
3. To detect duration of hospitalization and mortality rate in both groups.
4. To detect incidence and duration of mechanical ventilation in both treatment arms.
5. To monitor of adverse events of both drugs.

Conditions

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Covid19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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control

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily for 5 days.

Group Type PLACEBO_COMPARATOR

Remdesivir

Intervention Type DRUG

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily.

interventional

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.

Group Type EXPERIMENTAL

Lopinavir/ Ritonavir and Remdesivir combination

Intervention Type DRUG

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days

Interventions

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Remdesivir

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily.

Intervention Type DRUG

Lopinavir/ Ritonavir and Remdesivir combination

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg loading dose then 100 mg once daily and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days

Intervention Type DRUG

Other Intervention Names

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control intervention

Eligibility Criteria

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Inclusion Criteria

* Hospitalized adult patients with pneumonia evidenced by chest CT scan.
* Laboratory (RT-PCR) confirmed infection with 2019-nCoV or strongly suspected to be infected with SARS-COV2 with confirmation studies pending.
* And at least one of the following:

1. Respiratory frequency ≥30/min.
2. Blood oxygen saturation ≤93% on room air (RA).
3. Partial pressure of arterial oxygen to fraction of inspired oxygen ratio (PaO2/FiO2) \<300.
4. Worsening of lung involvement, defined as an increase in number and/or extension of pulmonary areas of consolidation, need for increased FiO2 to maintain stable O2 saturation, or worsening O2 saturation of \>3% with stable FiO2.

Exclusion Criteria

* Baseline elevation of alanine aminotransferase (ALT) or aspartate aminotransferase (AST) levels \> 5-fold the upper limit of the normal range.
* Pregnancy.
* Known hypersensitivity to drugs or any component of the formulation.
* Serious co-morbidity, including: Hepatic patients child Pugh class C.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No