COVID-19. Clinically-epidemiologically diagnosed COVID-19, Probable COVID-19, Suspected COVID-19
Conditions
Interventions
Intervention group: In addition to standard treatment:(two-drug regimen including 500 mg chloroquine phosphate / 400 mg hydroxychloroquine sulfate
single-dose and lopinavir/ritonavir 400/100 mg BID for at least 5 days or alternatively, atazanavir OR three-drug regimen including 500 mg chloroquine phosphate / 400 mg hydroxychloroquine sulfate
single-dose and lopinavir/ritonavir 400/100 mg BID for at least 5 days and ribavirin 1200 mg BID for at least 5 days)Remdesivir is also prescribed for 5 days (for patients over 40 kg or more: Amp Remd
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Ablility to fully understand, willingness to participate, and signing the informed consent form (in case of decreased level of consciousness or/ and cognitive impairment, informed consent is obtained from their legal representative) Ages over 18 years Patients with a definitive diagnosis of SARS-CoV-2 virus based on PCR with specific pulmonary involvement in radiography who have progressive hospital course (SpO2 30) despite receiving standard of care treatment protocols within 72 hours
Exclusion criteria
Exclusion criteria: Participants in any other clinical trial for COVID-19 Concomitant treatment with other antiviral drugs other than those recommended in the national protocol Patients undergoing mechanical ventilation at the time of baseline Evidence of multiorgan failure in the patient's clinical record based on the physician's diagnosis Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) above 5 times the upper limit of normal (ULN) Creatinine clearance less than 50 ml/min The presence of any concurrent major diseases including malignancy, advanced heart failure, cirrhosis, chronic kidney disease, stroke, Alzheimer's, chronic progressive neurological diseases, etc. Pregnant and lactating women Possibility of being transferred to another hospital with no access to the study drug (for any reason)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Clinical Improvement (TTCI): TTCI is defined as the time (in days) from initiation of study treatment until a decline of two categories from admission status on a six-category ordinal scale of clinical status which ranges from 1 (discharged) to 6 (death).6. Death; 5. ICU, requiring ECMO and/or IMV; 4. ICU/hospitalization, requiring NIV/ HFNC therapy;3. Hospitalization, requiring supplemental oxygen (but not NIV/ HFNC);2. Hospitalization, not requiring supplemental oxygen; 1. Hospital discharge. IMV, invasive mechanical ventilation; NIV, non-invasive mechanical ventilation;HFNC, High-flow nasal cannula. Timepoint: Daily for 14 days. Method of measurement: Based on clinical evaluation.;Time to Clinical recovery (TTCR): TTCR is defined as the time (in hours) from initiation of study treatment until normalization of fever, respiratory rate, and oxygen saturation, and alleviation of cough sustained for at least 72 hours.Normalization and alleviation criteria:• Fever - =36.9°C or -axilla, =37.2 °C oral,• Respiratory rate - =24/minute on room air,• Oxygen saturation - >94% on room air,• Cough - mild or absent on a patient-reported scale of severe, moderate, mild, absent. Timepoint: Daily for 14 days. Method of measurement: Based on clinical evaluation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with improved oxygen supply: Percentage of patients with improved oxygen supply (at least one step in reducing oxygen supply) including 1-no need for additional oxygen supply. 2. Nasal oxygen catheter inhalation 3. Oxygen inhalation with mask. 4- NIV 5- Ventilator. Timepoint: Daily for 14 days. Method of measurement: Based on clinical evaluation.;PaO2 / FiO2 ratio: lowest fraction recorded in a day. Timepoint: Daily for 14 days. Method of measurement: Oximeter.;The extent of lung involvement in CT scan. Timepoint: At baseline and 14th day. Method of measurement: Radiologist report basis.;Any adverse event. Timepoint: During the study period. Method of measurement: Any events during the study according to the patient's report or physician's judjment.;All cause mortality. Timepoint: During the 28 days after starting the intervention. Method of measurement: Hospital death record or statement by relatives after discharge. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactHamed Hosseini
Tehran University of Medical Sciences
Outcome results
None listed