The effect of Modafinil and placebo on improving consciousness in patients with COVID-19 with loss of consciousness

Determining the effect of prescribing Modafinil on improving consciousness in patients with COVID-19 with loss of consciousness.

The design of this study was a parallel. In terms of blinding, it is double blinded, which will be performed on 60 patients. For randomization was used of blocked method for patients in the drug group or placebo, based on the number assigned to patients. Medications (or placebo) for each patient were identified by a number on the box, which is the patient code, and are delivered to the nurse by the researcher.

Study will perform on COVID-19 patients in Rasoul Akram Hospital. After obtaining consent from patients or relatives and performing randomization, patients will be assigned into Modafinil and placebo arms. 30 patients are admitted in each arm. The third physician, who only has access to patient numbers, will measure the level of consciousness. Medafinil was administered orally or by gavage at a dose of 100 mg at 8 am and every two hours is administered 100 mg to reach a total dose of 400 mg. Consciousness (initial outcome) was assessed and in case of significant improvement in the level of consciousness according to the standard (GCS) measured by physician, drug should be continued at a dose of 400 mg daily for two weeks and if there is no change in consciousness according to the GCS standard Will be cut off. In the placebo group, patients will given oral placebo with a similar manner.

COVID-19 patients with declining in the level of conscioousness. Patients with adverse reaction to Modafinil and those with a history of seizure would remove from the study.

Patients with COVID-19 will be assigned into two groups Modafinil and placebo receiving with decreased level of consciousness.

Level of consciousness

The randomization process in this study is using by Random Allocation software. Which first defines the number of groups to the software and then determines the type of randomization. The randomization method is considered to be block type. In this method, in addition to reducing the differences between groups in terms of sample size, minimize the applying of researchers' opinions in assigning patients to study groups. Definition and output of randomization software is performed by the epidemiologist and the project manager knows the type of study groups and interventions. Each patient will be assigned a number taken from the Random Allocation software and each patient selected based on inclusion and non-inclusion criteria for the study will be notified to the project manager and he will announce the type of intervention based on patient Selected to study and match that number with the software output. Drug and placebo have the same shape and only the patient number will be written on it. Only the project manager will know the order of receiving the interventions as well as the type of interventions.

According to the randomization method, except the principle investigator, no other person is aware whether the patient is in the drug or placebo group. The participants and outcome assessor will be blinded regarding the patient's position in either trial groups.