The effect of Modafinil on improving consciousness with COVID-19

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
INTERVENTION: 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. CONDITION: Coronavirus 2019. ; COVID‐19, virus identified U07.1 PRIMARY OUTCOME: Headache. Timepoint: On admission and after 3 days. Method of measurement: Interview with the patient. Level of consiousnesa. Timepoint: On admission and after 3 days. Method of measurement: Glasgow Coma Scale. Seizure. Timepoint: On admission and after 3 days. Method of measurement: Observation, examination and recording data. SECONDARY OUTCOME: Biochemical laboratory data. Timepoint: Before intervention and daily in duration of intervention. Method of measurement: Laboratory kit. INCLUSION CRITERIA: Confirm patient with clinical feature, laboratory and chest CT scan Having mild decrease level of consiousness, drowsiness to deep coma
Epistemonikos ID: 2343fa3238ea38db7d6bb979ef01d66ad08a7f12
First added on: May 24, 2021