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Safety and Efficacy of Hydroxychloroquine Associated With Azithromycin in SARS-CoV2 Virus (Alliance Covid-19 Brasil II)

2020-03-31 04:04:33 | BioPortfolio

Summary

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract. Around 20% of those infected have severe pneumonia and currently there is no specific or effective therapy to treat this disease. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. But those efforts have not involved large, carefully-conducted controlled studies that would provide the global medical community the proof that these drugs work on a significant scale. In this way, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in patients hospitalized with pneumonia by SARS-CoV2 virus.

Description

The Severe Acute Respiratory Syndrome COronaVirus 2 (SARS-CoV2) is a new and recognized infectious disease of the respiratory tract that is now spreading to several countries in the world, including Brazil. Mortality rates after infection are higher in adults over 60 and with a history of comorbidities. The most serious patients need care in intensive care units (ICU). Most of the time they depend on mechanical ventilation support due to acute respiratory distress syndrome (ARDS). Infection rates are higher than the capacity for intensive care, which represents a serious problem in medical care. Around 20% of those infected have severe pneumonia and so far it does not have a specific therapy, or even, an effective clinical management. Therapeutic options using malaria drugs chloroquine and hydroxychloroquine have shown promising results in vitro and in vivo test. A recent, small, non-randomized study with hydroxychloroquine in 36 patients infected with SARS-Cov-2 proved to be promising in the ability to reset the viral load in 6 days after starting treatment. Thus, the present study will evaluate the effectiveness and safety of the use of hydroxychloroquine combined with azithromycin compared to hydroxychloroquine monotherapy in the clinical evolution by the ordinal scale of 7 points in adult patients hospitalized with pneumonia caused by infection by the SARS-CoV2 virus in Brazil.

Study Design

Conditions

Coronavirus Infections

Intervention

Hydroxychloroquine + azithromycin, Hydroxychloroquine

Location

Hospital Ana Nery
Salvador
Bahia
Brazil
05652-900

Status

Not yet recruiting

Source

Hospital Israelita Albert Einstein

Results (where available)

View Results

Links

Published on BioPortfolio: 2020-03-31T04:04:33-0400

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Medical and Biotech [MESH] Definitions

A chemotherapeutic agent that acts against erythrocytic forms of malarial parasites. Hydroxychloroquine appears to concentrate in food vacuoles of affected protozoa. It inhibits plasmodial heme polymerase. (From Gilman et al., Goodman and Gilman's The Pharmacological Basis of Therapeutics, 9th ed, p970)

An immunosuppressive agent used in combination with cyclophosphamide and hydroxychloroquine in the treatment of rheumatoid arthritis. According to the Fourth Annual Report on Carcinogens (NTP 85-002, 1985), this substance has been listed as a known carcinogen. (Merck Index, 11th ed)

A species in the genus CORONAVIRUS causing the common cold and possibly nervous system infections in humans. It contains hemagglutinin-esterase.

A species in the genus CORONAVIRUS causing upper and lower RESPIRATORY TRACT INFECTIONS. It shares the receptor used by the SARS VIRUS.

A species in the genus CORONAVIRUS causing the common cold and possibly nervous system infections in humans. It lacks hemagglutinin-esterase.

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