Evaluation of the efficacy and safety of Doxycycline in combination with standard treatment in Covid-19 patients: a clinical trial

Evaluation of efficacy and safety of doxycycline in combination with standard treatment in patients with COVID-19

Randomized controlled clinical trial, with intervention and control groups, without blinding, randomized, phase 3 per 60 patients, randomized by Permuted block randomization

This clinical trial will be performed on 60 patients aged 18 to 80 years in Shahid Sadoughi Hospital in Yazd. Patients are randomly divided into two intervention groups including doxycycline along with standard treatment and control group including standard treatment. At the beginning of the study, patients will be randomly assigned to one of two divided groups (30 people in each group). Patients in the intervention group receive doxycycline orally every 12 hours for 7 days along with standard treatment. Patients in the control group also receive placebo along with standard treatment. This study is a prospective randomized controlled clinical trial and will be performed on 60 patients who will be randomly assigned to two groups of 30 controls or intervention.

Minimum age 18 and maximum age 80 years, Signing up the informed consent form, Do not take ِdoxycycline during the past 5 days, Patients suspected of COVID-19 based on clinical signs and manifestations of CT scan, Candidate for outpatient treatment؛ Patients hospitalized, Patients with hemodynamic instability, Patients with a history of allergic reaction or allergy to doxycycline, Second and third trimesters of pregnancy

Intervention group: includes 30 patients who take 100 mg doxycycline capsules orally twice a day on the first to seventh days along with standard treatment. Control group: includes 30 patients who receive placebo along with standard treatment.

Improve clinical symptoms including fever; Cough; Shortness of breath

Block randomization (quadruple blocks) All possible blocks are arranged as follows: block 1: ABAB block 2: AABB block 3: ABBA block 4: BBAA block 5: BABA block 6: BAAB We need 15 blocks to select 60 people. We randomly select these blocks from the numbers 1 to 6.Using R software, we choose a random number between the numbers 1 to 6. For example, number 6 is chosen as the first block and number 2 as the forth block. The people who enter the study are given B-A-A-BA- A-B-B, respectively. Finally, group A receives control intervention and group B receives treatment intervention

The researcher is unaware that the medicine given to the patient is the main medicine or placebo. The participant (patient) is also unaware that the medicine being given to them is the main medicine or placebo.