Phage therapy for prevention of secondary bacterial pneumonia in COVID-19

Phase 3

Recruiting

Conditions: COVID-19.
COVID-19, virus identified
U07.1

Registration Number: IRCT20111224008507N6

Lead Sponsor: Mazandaran University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 60

Inclusion Criteria

Children and adults with moderate to severe COVID-19 (moderate: Evidence of pulmonary involvement or symptoms on imaging. severe: Respiratory rate more than 30 times per minute + percentage of blood oxygen saturation less than 93% + infiltration more than 50% in the lungs)
Having one of the following symptoms: Dry cough, severe weakness and fatigue, dyspnea, chest pain, fever greater than 38° C
Less than 3 days have passed since the first sign started
Definitive diagnosis of Covid-19 based on RT-PCR test or Involvement of a maximum of 3 or 4 pulmonary lobes with an area less than one third of the volume of each lobe or Infection of one or two lobes with a larger area in the patient's CT scan view

Exclusion Criteria

Patient who has previously had COVID-19 or has been hospitalized for COVID-19
Participate in any other clinical trial for the treatment of COVID-19
Bradycardia, abnormal primary ECG
Active cancer, immunodeficiency or treatment with immunosuppressive drugs
Underlying liver and kidney disease

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary pulmonary bacterial infection. Timepoint: Before the intervention and days 1 to 7, and 14 and 21 days after treatment. Method of measurement: Sputum culture, CT scan, clinical signs (fever, cough? ...).

Secondary Outcome Measures

Name	Time	Method
Blood oxygen saturation. Timepoint: 10 and 14 days after treatment. Method of measurement: Palsoxymeter.;Survival rate. Timepoint: After hospitalization. Method of measurement: Recoed of recovery or death.;Number of hospitalization days. Timepoint: Initiation of hospitalization until after discharge or death. Method of measurement: Number of days.;Number of days of intubation. Timepoint: Start intubation until the tube separates or death. Method of measurement: Number of days.;Number of days in the ICU. Timepoint: Start entering the ICU until discharge from the ICU. Method of measurement: Number of days.;Body temprature. Timepoint: Daily until 14 days. Method of measurement: Thermometer.;Cough. Timepoint: Daily until 14 days. Method of measurement: Observation and asking the patient.;Fatigue. Timepoint: Daily until 14 days. Method of measurement: Observation and asking the patient.