COVID-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Intervention group: In the intervention group,oral PTX (400 milligram TDS for up to 2 weeks) will be added to the routine treatment (hydroxychlroquine (400 milligram stat then 200 mili
Sponsors
Iran University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: Admitted patients with COVID-19 Moderate to severe disease Stable patients Patients should not have bleeding disorders Patients do not have a history of heart attack and stroke Patients without history of ocular or cerebral hemorrhage No pregnancy or breastfeeding Patients without history of intolerance to PTX or other xanthines such as caffeine, theophylline and tobromine Patients without gastric ulcers Patient without history of porphyria Patients with no prominent renal or hepatic or cardiac dysfunction Patients without history of major surgery in the past 2 weeks Patients without history of cancer Patients without need to use any therapeutic blood thinners, including aspirin and warfarin
Exclusion criteria
Exclusion criteria: Allergy to any of the drugs studied, including pentoxifylline Occurrence of any bleeding during the study (in the stomach, brain, eyes, ...) Drug intolerance or the occurrence of any severe side effects during treatment, such as gastrointestinal intolerance, does not respond to pre-determined measures of anti-acids... or the occurrence of skin drug reactions to the received treatment protocol and ... Being pregnant during the study Occurrence of heart attack and stroke during the study Drop in pressure below 10 mm Hg or instability of the patient's vital signs Require intubation during study or hospitalization in the ICU Increase in the severity of COVID-19 disease during the study so that the need for hospitalization in the ICU or the need to change the treatment protocol The use of a therapeutic drug other than the standard drug in this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to improve symptoms such as cough, shortness of breath and lethargy. Timepoint: At the beginning of the hospitalization/ two weeks after treatment. Method of measurement: Clinical evaluation.;O2 saturation. Timepoint: At the beginning of the hospitalization/ two weeks after treatment. Method of measurement: Clinical evaluation and pulse oximetery.;Re-hospitalization after discharge. Timepoint: At the beginning of the hospitalization/ two weeks after treatment. Method of measurement: Clinical evaluation.;Duration of hospitalization. Timepoint: After discharge. Method of measurement: Days.;Evaluation of laboratory parameters as a series of factors: PCR and LDH, CBC, ESR, CRP. Timepoint: At the beginning of the hospitalization/ during hospitalization/ at discharge time. Method of measurement: Lab data analysis.;Check for changes in anti-inflammatory parameters (TNF-ALPHA and IL-6 if measuring kits are available). Timepoint: At the beginning of the hospitalization/ at discharge time. Method of measurement: Lab data analysis.;Investigation of radiological changes at the beginning of hospitalization and during hospitalization if possible. Timepoint: At the beginning of the hospitalization/ during hospitalization. Method of measurement: Radiographic changes.;Need to ICU admission. Timepoint: During hospitalization. Method of measurement: Clinical evaluation.;Recovery or death. Timepoint: During hospitalization or in follow-up period. Method of measurement: Observation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Side effects. Timepoint: Time to start the intervention/ during hospitalization, two weeks after interventions. Method of measurement: Clinical, laboratory evaluation.;Need change initial treatment or add new drug to the regimen. Timepoint: During hospitalization. Method of measurement: Clinical assessment. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactAzadeh Goodarzi
Iranshahr University of Medical Sciences
Outcome results
None listed