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

Clinical trial of ealuation of phage therapy with nebulizer in prevention of secondary bacterial pneumonia in admitted patients with moderate to severe COVID-19

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20111224008507N6
Enrollment
60
Registered
2021-05-07
Start date
2021-05-10
Completion date
Unknown
Last updated
2021-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19. COVID-19, virus identified

Interventions

Intervention 1: Intervention group: For 7 days, once daily, 10 ml of bacteriophage cocktail solution with a titer of one trillion pfu (Plaque Forming Units) per ml is nebulized once a day. Interventio

Sponsors

Mazandaran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
4 Years to No maximum

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactDr Mohammad Sadegh Rezai

Mazandaran University of Medical Sciences

rezai@mazums.ac.ir+98 15 1325 7230

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026