The effect of pentoxifylline on hypoxia in non-intubated covid-19 patients hospitalized in the intensive care unit - randomized controlled clinical trial

The effect of pentoxifylline on hypoxia in non-intubated covid-19 patients hospitalized in the intensive care unit - randomized controlled clinical trial

Clinical trial with intervention and control group, double-blind, randomized,parallel, phase 3 is performed on 100 patients

This study is performed on patients Covid 19 admitted to the intensive care unit of Vali-e-Asr Hospital in Birjand. after explaining the objectives of the study in the eligible group and obtaining patient satisfaction, patients is divided into two groups of intervention and control. It is randomly divided and the intervention is performed based on the study group. The study is blind for the patient and the intervening and analyzing person.

Admission requirements: confirmation of Covid-19 diagnosis by PCR test informed consent to participate in the study No history of allergy to methylxanthines Being hospitalized in the intensive care unit The patient should not be intubated arterial oxygen saturation less than 85% without oxygen therapy(room air or ambient air) Don t admission requirements: pregnancy and lactation Severe liver failure Severe renal failure Bleeding disorder and coagulopathy Hypersensitivity to the pentoxifylline(After prescribing)

Both study groups will receive standard treatment. The intervention group will receive 400 mg oral pentoxifylline tablets made in Iran, Farabi Pharmaceutical Company with generic code 00970, three times a day ( every 8 hours) for 72 hours, and the control group will receive placebo. The placebo prepared by Farabi Pharmaceutical Company will be taken orally three times a day ( every 8 hours) for 72 hours.

Atrial Oxygen saturation, Measure of Arterial blood oxygen ,Blood Pressure

In this study, the randomized block method is used as four blocks with equal proportions of groups. The different permutations of the blocks (AABB, BABA, BBAA, ABBA, ABAB, and BAAB) will be numbered from one to six and then the random selection of blocks will be done using dice.

For blinding, drug and placebo are exactly the same in terms of color, taste and packaging, and concealment by inserting a special row number / code in column A and B in Excel, on the drug and placebo box, the candidate , The evaluator and the analyst remain unaware of the type of intervention.

Some of the information obtained will be available based on change in initial out comes.

Start of access period 6 month after production and publication of results.

People engaged in medical universities of the country.

The methods and data contained in this clinical trial should be used solely to advance similar projects.it is also necessary to mention the research center of this study (Birjand university of medical sciences)

Dr Mahmoud Gnjifard,fardganj@gmail.com,Birjand university of medical sciences

Contact the scientific or general respondent of the study Sending their official request to the respondent Apply the university Research council In case of a positive response from the council, It will be provided to the applicant in accordance with the ethics principles The total duration of the process from the time of receiving the request in 20 days.