Effect of Dinvl on improving of clinical and paraclinical symptoms in patients with COVID-19

Phase 3

Conditions: COVID-19.
Novel Cronavirus Disease (COVID-19)
U07.01

Registration Number: IRCT20200518047497N2

Lead Sponsor: Zahravi Pharmaceutical Company

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Pending

Sex: All

Target Recruitment: 80

Inclusion Criteria

COVID-19 patients aged 15 years and older who newly admitted (first day of hospitalization)
Having definite COVID-19 disease
Obtaining informed consent to participate in the trial
Non-participation in another clinical trial simultaneously

Exclusion Criteria

Epilepsy
Having liver or renal failure according to the patient's statement, physician examination or based on creatinine, SGOT, SGPT, LDH tests.
Immunodeficiency (treated with Corticosteroids over 12.5 mg / d Prednisolone for more than two weeks, chemotherapy, malignancies, organ transplants, HIV patients, other viral diseases.
Having other infectious diseases according to the diagnosis of the physician and the information of medical record.
Pregnancy (according to the patient's statement and examination by a physician).
Breastfeeding (according to the patient's statement).

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Respiratory Rate. Timepoint: Daily. Method of measurement: Observation.;Oxygen saturation (SpO2). Timepoint: Daily. Method of measurement: Pulse Oximeter.;Serum White Blood Cell count. Timepoint: Before- 14 days after intervention. Method of measurement: Laboratory cell counter.;Serum CRP level. Timepoint: Before- 14 days after intervention. Method of measurement: Biochemical method.;ESR (Erythrocyte Sedimentation Rate). Timepoint: Before- 14 days after intervention. Method of measurement: Checking the sedimentation rate of erythrocytes in a special tube within one hour.;Number of hospitalization days. Timepoint: After intervention. Method of measurement: Questionnaire.;Mortality. Timepoint: Daily. Method of measurement: Questionnaire.

Secondary Outcome Measures

Name	Time	Method
The time of absence of dry Cough. Timepoint: Daily. Method of measurement: ?Daily symptom recording questionnaire.;The time of absence of trembling. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire.;The time of absence of sore throat. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire.;The time of absence of dry Cough. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire.;The time of absence of difficulty in breathing or shortness of breath. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire.;The time of absence of temperature equal to or grater than 37.8 C. Timepoint: Daily. Method of measurement: Daily symptom recording questionnaire.;Body temperature. Timepoint: Daily. Method of measurement: Thermometer.;Side effects. Timepoint: Daily. Method of measurement: Side effects checklist.