Clinical trial NCT04361461: Use of Hydroxychloroquine Alone or Associated for Inpatients With SARS-CoV2 Virus (COVID-19)
Official title: Hydroxychloroquine or Hydroxychloroquine Associated With Azithromycin for Inpatients With Moderate or Severe Lung Disease Due to SARS-CoV-2 (COVID-19)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Coronavirus Infections
SARS-CoV 2
SARS (Severe Acute Respiratory Syndrome)
Pulmonary Disease
Lead sponsor: Apsen Farmaceutica S.A.
Sponsor class: INDUSTRY
Collaborators: name: Federal University of São Paulo
First posted: 2020-04-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV2) has been identified in Wuhan, China, which causes severe pulmonary complications and flu syndrome, which has spread rapidly to all continents. Approximately 25% of hospitalized patients require treatment in intensive care units and 10% require mechanical ventilation. The diagnosis is made by the molecular polymerase chain reaction test. However, diagnostic tests are limited. The clinical care of the patient with COVID-19 is similar to that of patients with severe infectious respiratory complications, consisting of support and oxygen supplementation. Several medications have been tested as remdesivir, a pro-drug nucleoside, which acts by inhibiting viral RNA transcription, although a recently published study has shown no benefit. China recently approved the use of favipiravir, an antiviral used for influenza, as an experimental therapy for COVID-19. Hydroxychloroquine is a drug with great potential treatment, as it can inhibit the pH-dependent steps of replication of various viruses, with a potent effect on SARS-CoV infection and spread. In this way, the present study will evaluate the safety and efficacy of the hydroxychloroquine in patients with symptomatic SARS-Cov2.


Eligibility criteria: Inclusion Criteria:

* Males and females aged \> 18 years;
* Patients with flu syndrome (fever greater than 37.8C or feverish feeling referred by the patient associated with at least 1 respiratory symptom: cough, difficulty breathing, sputum production, nasal or conjunctival congestion, difficulty swallowing, sore throat, runny nose, signs cyanosis, flapping of the nose and dyspnoea);
* Diagnosis confirmed by real-time PCR or suspected COVID-19;
* Hospitalized patients with:
* Moderate disease: hypoxemia with O2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute and / or radiological evidence of pneumonia with pulmonary impairment less than 50%;

or

* Serious illness: Hospitalized patients with hypoxemia with O2 saturation \<93% in room air and / or respiratory rate greater than or equal to 24 incursions per minute with radiological evidence of pneumonia with pulmonary involvement above 50% and / or the presence of sepsis ( organ failure) or need for invasive mechanical ventilation.

Exclusion Criteria:

* Mild cases of flu-like syndrome that do not require hospitalization or O2 saturation greater than or equal to 93% and without radiological evidence of pneumonia;
* Liver failure or elevation of transaminases greater than 5 times;
* Cardiac patients with electrocardiogram with extended QT interval;
* Pregnant women;
* Use in the last 30 days of hydroxychloroquine or azithromycin;
* Allergy to hydroxychloroquine or azithromycin.

Primary outcomes:
measure: Individual response rate
timeFrame: 14 days after randomization
Secondary outcomes:
measure: All-cause mortality
timeFrame: 28 days after randomization
measure: Duration of mechanical ventilation
timeFrame: baseline
measure: Proportion of patients which needed mechanical ventilation during study
timeFrame: hospitalization within 28 days
measure: World Health Organization (WHO) Ordinal scale
timeFrame: 28 days after inclusion and compared to baseline
measure: Duration of hospitalization
timeFrame: hospitalization within 28 days
measure: Rates of drug discontinuation
timeFrame: hospitalization within 28 days
Other outcomes:
measure: Rates of serious adverse events
timeFrame: Day 14th
Locations:
city: São Paulo
country: Brazil
facility: Apsen Farmacêutica S.A.
Study officials:
References: