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Study aim: Evaluating the effectiveness of CURCUDEN products as adjunctive therapy in the treatment of pneumonia in patients with COVID-19 Design: A phase 3 randomized clinical trial with control and intervention groups, double blinded,20 patients, allocated concealment by the central randomization method. Settings and conduct: Intervention group receives 2 capsules of CURCUDEN® every 12h with the recommended treatment regimen for COVID-19 according to the national protocol.From the day of entrance,the Sepsis-related Organ Failure Assesment standard for calculating respiratory,cardiovascular,neurological,renal,coagulation and hepatic function is calculated and its average is reported.Also,the criterion for classification of 7 (category-ordinal scale), complete counting and differentiation of blood cells (CBC diff, acute phase C protein, erythrocyte sedimentation rate and prothrombin time , lactate dehydrogenase, creatine phosphokinase, ferritin, creatinine, and the National Early Warning Criteria 2 were measured on days 1, 5, and fourteen of treatment, compared with control group. Measurements of interleukin 6 levels, RT-PCR virus testing, and CT scans of the lungs are also performed on days one and five of treatment. Participants/Inclusion and exclusion criteria: Inclusion criteria: Virological diagnosis of SARS-CoV-2 infection by RT-PCR Positive imaging findings: Condensation, Grand Glass turbidity or bilateral pulmonary infiltration on CT scan or Chest X-ray Need to get extra oxygen to maintain SO2> 94% or PaO2 / FiO2> 300 Exclusion criteria : less than 18 years Septic shock Pregnancy and lactation Intubated and under mechanical ventilation Allergic to curcumin Admitted to the ICU Intervention groups: Every 12h, Intervention group received 2 CURCUDEN capsules & Control group, takes 2 placebos in addition to the main treatment protocol Main outcome variables: SOFA; RT-PCR; CPK; CRP; Ferritin; IL-6
IRCTID: IRCT20170128032241N3