Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2025-12-24 @ 4:56 PM
NCT ID:
NCT05043350
Brief Summary:
The use of antihistaminic medications could result in a significant immune modulation which may help in the treatment of cytokine storm of COVID-19.Thus, the aim of this study is to evaluate efficacy and safety of famotidine and loratadine combination in covid 19 treatment protocol.
Detailed Description:
On admission to hospital, the patient will be diagnosed for suspected COVID-19 based primarily upon pulmonary symptoms, and will be confirmed positive for COVID-19 by RT-PCR diagnostic test and then will be located within a COVID-19 ward. According to Ministry of Health guidelines, moderate cases of COVID 19 will be identified if the Patient has pneumonia manifestations on radiology associated with symptoms (fever, cough, general weakness /fatigue, headache, sore throat, anorexia, diarrhea and vomiting) and / or leucopenia or lymphopenia.
Treatment will be initiated in ER with standard of care per admitting provider. Standard of care includes radiologic assessments, supplemental oxygen when necessary, and intravenous (IV) hydration when necessary. In addition to concomitant treatments like the antimalarial drug hydroxychloroquine, the anti-inflammatory drug dexamethasone (IV).plus, Famotidine 40 mg po twice daily and loratadine 10 mg po once daily (Interventional group) and Control group will receive standard drug therapy according to the treatment protocols of the National Committee of COVID-19 + Famotidine 40 mg twice daily po. The COVID-19 standard of care as provided by the ministry of health is attached in appendix1.Blood samples will be withdrawn from the patients at baseline and every 7 days to assess the following parameters using routine laboratory methods Complete blood picture: Lymphopenia, eosinopenia, neutrophil/lymphocyte ratio and platelet count, C-reactive protein and ferritin, lactate dehydrogenase (LDH), d-dimer Cardiac markers, IL-6, Procalcitonin, Prothrombin time, Activated partial thromboplastin time, Creatine kinase (CK), Glutamic-pyruvic transaminase (SGPT) and Urea, and serum creatinine to determine the incidence of organ failure Sample handling: Syringes used in sample withdrawal will be discarded in appropriate safety box and serum samples will be discarded in biohazards box. These biohazard waste will be sent to incinerators through the hospital laboratory as per hospital protocol.
Precaution against infections:
The principal investigator and all healthcare professional must wear full protective personal equipment (PPE) as per hospital protocol including full gown, full facial mask and safety gloves when in direct contact with patients for follow ups. These PPE are removed before the exit of COVID-19 ward and discarded as hazard waste. Disinfectant will be used by all personal before leaving the ward
Study:
NCT05043350
Study Brief:
Protocol Section:
NCT05043350