Comparative Therapeutic Efficacy and Safety of Different Antiviral and Anti Inflammatory Drugs 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

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-01

Study Completion Date

2021-04-05

Brief Summary

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Comparison outcomes of a large cohort of moderate and severe COVID-19 patients received different Antiviral and Anti Inflammatory Drugs.

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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.
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 Pneumonia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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group 1

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days and Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days plus tocilizumab 800 mg once

Group Type ACTIVE_COMPARATOR

Remdesivir

Intervention Type DRUG

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days.

Tocilizumab

Intervention Type DRUG

Tocilizumab 800 mg once.

Lopinavir/ Ritonavir

Intervention Type DRUG

Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.

group 2

Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days and Ivermectin 36 mg at day 1,3 and 6 plus tocilizumab 800 mg once.

Group Type ACTIVE_COMPARATOR

Hydroxychloroquine

Intervention Type DRUG

Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days.

Tocilizumab

Intervention Type DRUG

Tocilizumab 800 mg once.

Ivermectin

Intervention Type DRUG

Ivermectin 36 mg at day 1,3 and 6.

Interventions

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Remdesivir

Remdesivir will be administrated intravenously (IV) at a dose of 200 mg at day 1 then 100 mg once daily for 5 days.

Intervention Type DRUG

Hydroxychloroquine

Hydroxychloroquine will be administrated at a dose of 400 mg twice daily at day 1 then 200 mg twice daily for 5 days.

Intervention Type DRUG

Tocilizumab

Tocilizumab 800 mg once.

Intervention Type DRUG

Lopinavir/ Ritonavir

Lopinavir / ritonavir at a dose of 400 /100 once daily for 5 days.

Intervention Type DRUG

Ivermectin

Ivermectin 36 mg at day 1,3 and 6.

Intervention Type DRUG

Other Intervention Names

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Actemra kaletra Iverazine

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 \> 3-fold the upper limit of the normal range.
* Pregnancy.

Minimum Eligible Age

18 Years

Maximum Eligible Age

88 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No