Effect of nanocurcumin supplementation on the severity of symptoms and length of hospital stay in patients with COVID-19

The aim of this study is to determine the effect of nanocurcumin supplementation on serum level of hs-CRP, the severity of symptoms and length of hospital stay in patients with COVID-19.

The present study is a parallel randomized clinical trial with a control group.

Patients will be randomly divided to two groups of 24: intervention group (receiving nanocurcumin supplement) and control group (receiving placebo). Height, weight, and waist circumference will be measured and questionnaires for severity of infection symptoms of upper and lower respiratory tract will be filled out. Ten milliliter fasting blood will be taken from all patients at the beginning and end of the intervention.

Patients aged 30 to 70 years with confirmation of COVID-19 (having a positive PCR test or involved lung CT-scan) who do not require ICU admission will be included in the study. Patients with a history of chemotherapy, organ transplants, malignancies, dialysis, CABG, liver failure, HIV, heart attack and stroke in the past 3 months, uncontrolled diabetes, known food allergies, and people with BMI over 40 and pregnant and lactating women will not be included in the study.

The intervention group will receive 4 capsules daily, each containing 40 mg of nanocurcumin, and the control group will receive 4 placebo capsules daily, which is completely similar to the nanocurcumin supplement, for 6 days.

hs-CRP, recovery percentage, percentage of oxygen saturation, severity of infection symptoms of upper and lower respiratory tract, CBC

Randomization is done by permuted block method. First, all possible quadruple blocks are considered and a number is assigned to each of them. Then, using a table of random numbers and the number assigned to each block, a random sequence is determined. Eligible individuals included in the study are placed in the intervention or control group according to the sequence determined based on randomization.

In order to keeping patients, clinical caregivers, and the outcome assessor blind, the placebo will be prepared of the same color and shape as the supplement so that no one could distinguish the supplement from the placebo. The main researcher, who is not in direct contact with patients, is the only person who is not blind and pours supplements and placebos into exactly the same cans, specifies the cans with a three-digit number in no particular order and gives the cans to the outcome assessor, who is responsible for entering patients into the study and giving them the supplements. The randomization sequence will be kept by the main researcher, and he/she will inform the outcome assessor that which can (based on the three-digit code) should be given to the next patient. In this way, the outcome assessor is not able to interfere with the order of patients' entering and will be completely blind to the contents of the can that should be given to the next patient.