Chloroquine Diphosphate for the Treatment of Severe Acute Respiratory Syndrome Secondary to SARS-CoV2 (CloroCOVID19)
SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia
About this trial
This is an interventional treatment trial for SARS-CoV Infection focused on measuring COVID-19, SARS-CoV Infection, Severe Acute Respiratory Syndrome (SARS) Pneumonia, Chloroquine Diphosphate, Clinical trial
Eligibility Criteria
Inclusion criteria:
- Male and female participants aged over 18 years old
- Hospitalized
presenting:
- respiratory rate higher than 24 breathing incursions per minute AND/OR
- heart rate higher than 125 beats per minute (in the absence of fever) AND/OR
- peripheral oxygen saturation lower than 90% in ambient air AND/OR
- shock (defined as mean arterial pressure less than 65 mmHg, requiring vasopressor or oliguria or lowering level of consciousness)
Exclusion Criteria:
β’ None.
Sites / Locations
- Hospital e Pronto Socorro Delphina Rinaldi Abdel Aziz
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Active Comparator
Placebo Comparator
Active Comparator
Low Dose Chloroquine Diphosphate (5 days) (Study stage 1) - Clorocovid 1
High Dose Chloroquine Diphosphate (10 days) (Study stage 1) - Clorocovid 1
Placebo (5 days) (Study stage 2) - Clorocovid 3
Low Dose Chloroquine Diphosphate (5 days) (Study stage 2) - Clorocovid 3
Low dose chloroquine group consists of 450 mg bid (3 tablets of 150 mg + 1 placebo tablet, every 12 hours) on D1, 3x150mg tablets + 1 placebo followed by 4 placebo tablets 12h later from D2 to D5, and 4 placebo tablets every 12 hours, D6-D10 . Oral administration or via nasogastric tube in case of orotracheal intubation. (this was the first stage of the original study and was approved by the Brazilian IRB on 23/March/2020).
High dose chloroquine group consists of 600 mg bid (4 tablets of 150 mg, every 12 hours) for 10 days. Oral administration or via nasogastric tube in case of orotracheal intubation. (this was the first stage of the original study and was approved by the Brazilian IRB on 23/March/2020).
Placebo group consists of 3 placebo tablets bid (day 1), and 3 placebo tablets once daily from D2 to D5. Oral administration or via a nasogastric tube in case of orotracheal intubation. (this was a second stage of the original study and was approved by the Brazilian IRB on 03/May/2020).
Low dose chloroquine group consisted of 450 mg bid (3 tablets of 150 mg) on D1, and 3x150mg tablet once daily from D2 to D5. Oral administration or via a nasogastric tube in case of orotracheal intubation. (this was a second stage of the original study and was approved by the Brazilian IRB on 03/May/2020).