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临床试验/NCT05043350
NCT05043350已完成2 期

Potential Therapeutic Outcome of Combined Antihistaminics Therapy in COVID 19 Patients

Ain Shams University1 个研究点 分布在 1 个国家目标入组 214 人开始时间: 2021年9月13日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
214
试验地点
1
主要终点
Assessment of the number of patients who will need vasopressor due to progression to shock

研究概览

简要总结

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.

详细描述

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 The COVID-19 standard of care as provided by the ministry of health is attached in appendix1.Blood samples will be withdrawn from the patients at baseline and every 7 days to assess the following parameters using routine laboratory methods Complete blood picture: Lymphopenia,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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

性别
All
接受健康志愿者

入选标准

  • Adult patients (>18 years old).
  • Confirmed COVId-19 infection with PCR.
  • Moderate covid patients who with Sp02 <92 %
  • CT chest infiltration more than 50 %
  • Presented to the hospital within 24 to 48 hours
  • CBC (WBCs may be normal or high or low with lymphocytopenia is present, decreased hemoglobin, neutrophilia with neutrophil/lymphocyte ratio > 3.1)

排除标准

  • Hepatic or renal failure: (Alanine transaminase or Aspartate transaminase >3 times above the normal limit)
  • History or evidence of long QT segment on Electrocardiogram,
  • Pregnancy or breast-feeding mother
  • Patient on mechanical ventilator.
  • Patient who received vaccine.
  • Patients receiving antidepressants, opioids, (e.g., anticonvulsants, clonazepam).

研究组 & 干预措施

Interventional group

Experimental

107 patients will receive standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 in addition to IV famotidine 40 mg twice daily (Manufactured by AMOUN Pharmaceutical Company) until the day of discharge + LORATIDINE (Manufactured by AMOUN Pharmaceutical Company)Oral: 10 mg once daily.

干预措施: Loratadine (Drug)

Interventional group

Experimental

107 patients will receive standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 in addition to IV famotidine 40 mg twice daily (Manufactured by AMOUN Pharmaceutical Company) until the day of discharge + LORATIDINE (Manufactured by AMOUN Pharmaceutical Company)Oral: 10 mg once daily.

干预措施: Famotidine (Drug)

Control group

Active Comparator

107 patients will receive standard drug therapy according to the treatment protocols of the National Committee of COVID-19 in addition to IV famotidine 40 mg twice daily (Manufactured by AMOUN Pharmaceutical Company)

干预措施: Famotidine (Drug)

结局指标

主要结局

Assessment of the number of patients who will need vasopressor due to progression to shock

时间窗: during hospital stay (Up to 28 days)

Assessment of number of patients who will need Mechanical ventillation

时间窗: during hospital stay (Up to 28 days)

次要结局

  • Assessment of Duration (number of days) the patients will need oxygen support therapy(during hospital stay (Up to 28 days))

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Samar Saad elDeen Azab

Professor of Pharmacology & Toxicology

Ain Shams University

研究点 (1)

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