evaluation of Safety and efficacy of anti inflammatory regimens in COVID-19

Safety and efficacy of “Hydroxychloroquine + Azithromycin + Naproxen + Prednisolone” and “Hydroxychloroquine + Azithromycin + Naproxen” regimens in comparison with “Hydroxychloroquine + kaletra” on the need for intensive care unit treatment in patients with COVID-19; a randomized, multicenter, parallel groups, open label study

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20200318046812N2

Enrollment

906

Registered

2020-04-08

Start date

2020-04-10

Completion date

Unknown

Last updated

2020-05-18

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

Conditions

COVID-19. COVID-19

Interventions

Intervention 1: Intervention group: Intervention group: Group 1: Patients in this group will first receive hydroxychloroquine as two 200 mg tablets with a total of 400 mg of stat

then the following regimen will be continued for 5 days - azithromycin two 250 mg tablets on the first day. And then 250 mg daily for 5 days - 5 mg prednisolone tablets in the amount of 5 tablets (25

then the following diet will be continued for 5 days.- Azithromycin two 250 mg tablets on the first day and then 250 mg daily for 5 days- Naproxen tablets 250 mg twice daily for 5 daysIn addition, pat

Eligibility

Sex/Gender

All

Age

16 Years to 100 Years

Inclusion criteria

Inclusion criteria: Diagnosis of COVID-19 based on either ground glass appearance in chest CT scan or positive RTPCR test for COVID-19 Requiring hospitalization Patient's age between 16 and 100 years Signed informed consent form

Exclusion criteria

Exclusion criteria: Past history of hospitalization or treatment in hospital for COVID-19 disease Receiving other antiviral medications such as (Hydroxychloroquine, Kaletra, Ribavirin, Oseltamivir) Uncontrolled diabetes Astma Chemotherapy in the past month Taking immunosuppressive drugs Chronic liver or renal failure Taking daily systemic corticosteroids HIV GI bleeding Pregnancy or Lactation Uncontrolled bacterial infection

Design outcomes

Primary

Measure	Time frame
Admission to intensive care unit. Timepoint: Once (when admitted to intensive care unit). Method of measurement: Hospital records.	—

Secondary

Measure	Time frame
In-hopital mortality. Timepoint: Once. Method of measurement: Patient medical records.;Length of stay in hospital. Timepoint: Once at discharge. Method of measurement: Patient medical records.;Radiological Treatment Response (CT scan) , more than 50% reduction in the a?ected area. Timepoint: CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the ?rst one. Method of measurement: Patient CT scan.;Laboratory Treatment Response; return of blood cell count and CRP values to normal. Timepoint: Daily. Method of measurement: Laboratory kits.;Fever. Timepoint: Daily. Method of measurement: Patient medical records.;Dyspnea. Timepoint: Daily. Method of measurement: Patient medical records.;Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes. Timepoint: 4 times a day while in the wards. Method of measurement: Observation.;Oxygen therapy maximum ?ow during the day (lit/min). Timepoint: Daily. Method of measurement: Patient medical records.;Discharge without Intensive care need. Timepoint: Once. Method of measurement: Patient medical records.;Pulmonary function. Timepoint: 6 weeks after discharge. Method of measurement: Spirometry and a six-minute walking test are performed. Pulmonary function status is divided into two groups, normal and abnormal.;Allergic drug reaction. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms.;Adverse drug reactions. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms.	—

Measure

Time frame

In-hopital mortality. Timepoint: Once. Method of measurement: Patient medical records.;Length of stay in hospital. Timepoint: Once at discharge. Method of measurement: Patient medical records.;Radiological Treatment Response (CT scan) , more than 50% reduction in the a?ected area. Timepoint: CT scan will be done twice (once at the time of admission and the second time 10 days after discharge). Assessment will be done comparing the second CT with the ?rst one. Method of measurement: Patient CT scan.;Laboratory Treatment Response; return of blood cell count and CRP values to normal. Timepoint: Daily. Method of measurement: Laboratory kits.;Fever. Timepoint: Daily. Method of measurement: Patient medical records.;Dyspnea. Timepoint: Daily. Method of measurement: Patient medical records.;Oxygen saturation without supplemental oxygen. Measurement will be done after discontinuation of oxygen therapy for 5 minutes. Timepoint: 4 times a day while in the wards. Method of measurement: Observation.;Oxygen therapy maximum ?ow during the day (lit/min). Timepoint: Daily. Method of measurement: Patient medical records.;Discharge without Intensive care need. Timepoint: Once. Method of measurement: Patient medical records.;Pulmonary function. Timepoint: 6 weeks after discharge. Method of measurement: Spirometry and a six-minute walking test are performed. Pulmonary function status is divided into two groups, normal and abnormal.;Allergic drug reaction. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms.;Adverse drug reactions. Timepoint: Daily. Method of measurement: Adverse Drug Reaction forms.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactSeyed Hassan Saadat

Bagheiat-allah University of Medical Sciences

saadat350@gmail.com+98 21 8860 0067

Outcome results

None listed

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