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IRCT20170903036041N3 IRCT 2021-05-23 Iran University of Medical Sciences The effect of Modafinil on improving consciousness with COVID-19 The effect of Modafinil and placebo on improving consciousness in patients with COVID-19 with loss of consciousness 2021-05-05 anticipated 60 Complete https://irct.ir/trial/54376 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Coronavirus 2019. Intervention 1: Intervention group: Modafinil (100 mg Tablets) is administered orally or by gavage at the rate of 100 mg every 8 hours and in case of no complications or changes in hemodynamics, 100 mg every two hours is re-prescribed up to 400 mg, reach the total dose (plasma peak of the drug is 2-4 hours). Two hours after each dose and before the next dose and two hours after the last dose (10, 12, 14 and 16 hours) consciousness (initial outcome) was assessed and in case of significant improvement in the level of consciousness according to Glasgow criteria coma scale (GCS) The drug is continued for up to two weeks at a dose of 400 mg daily and will be discontinued if there is no change in consciousness according to the GCS standard. In addition, all treatment measures will be conducted according to the national therapeutic protocol for the patients. Intervention 2: Control group: In this group, placebo will be prescribe to the patients which have no therapeutic effect and are similar in color and shape to Medafinil tablets. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No decision has been made yet
public Maziar Emamikhah
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9260 maziar.emamikhah@yahoo.com Iran University of Medical Sciences scientific Maziar Emamikhah
Rasoul Akram hospital, Niyayesh St, Sattarkhan St
Tehran Iran (Islamic Republic of) 1445613131 +98 21 6653 9260 maziar.emamikhah@yahoo.com Iran University of Medical Sciences Iran (Islamic Republic of) Confirm patient with clinical feature, laboratory and chest CT scan Having mild decrease level of consiousness, drowsiness to deep coma no limit no limit Both History of seizure Clinical feature accompanied after drug cosumption Drug side effects U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs Intervention group: Modafinil (100 mg Tablets) is administered orally or by gavage at the rate of 100 mg every 8 hours and in case of no complications or changes in hemodynamics, 100 mg every two hours is re-prescribed up to 400 mg, reach the total dose (plasma peak of the drug is 2-4 hours). Two hours after each dose and before the next dose and two hours after the last dose (10, 12, 14 and 16 hours) consciousness (initial outcome) was assessed and in case of significant improvement in the level of consciousness according to Glasgow criteria coma scale (GCS) The drug is continued for up to two weeks at a dose of 400 mg daily and will be discontinued if there is no change in consciousness according to the GCS standard. In addition, all treatment measures will be conducted according to the national therapeutic protocol for the patients. Control group: In this group, placebo will be prescribe to the patients which have no therapeutic effect and are similar in color and shape to Medafinil tablets. Level of consiousnesa. Timepoint: On admission and after 3 days. Method of measurement: Glasgow Coma Scale. Headache. Timepoint: On admission and after 3 days. Method of measurement: Interview with the patient. Seizure. Timepoint: On admission and after 3 days. Method of measurement: Observation, examination and recording data. Biochemical laboratory data. Timepoint: Before intervention and daily in duration of intervention. Method of measurement: Laboratory kit. Iran University of Medical Sciences Approved 2020-12-26 Ethics committee of Iran university of Medical Sciences Iran University of Medical Sciences, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)