Combined Antihistaminics Therapy in COVID 19 Patients

Potential Therapeutic Outcome of Combined Antihistaminics Therapy in COVID 19 Patients

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.

Study Overview

• Status: Completed
• Conditions: Covid19
• Intervention / Treatment: Drug: Loratadine; Drug: Famotidine

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 The COVID-19 standard of care as provided by the ministry of health is attached in appendix1.Blood samples will be withdrawn from the patients at baseline and every 7 days to assess the following parameters using routine laboratory methods Complete blood picture: Lymphopenia,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 Type: Interventional
• Enrollment (Actual): 214
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt, 11765
    • Nasr City Insurance Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; 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.	Drug: Loratadine; 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.; Drug: Famotidine; 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.
Active Comparator: Control group; 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)	Drug: Famotidine; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Assessment of number of patients who will need Mechanical ventillation	during hospital stay (Up to 28 days)
Assessment of the number of patients who will need vasopressor due to progression to shock	during hospital stay (Up to 28 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of Duration (number of days) the patients will need oxygen support therapy	the duration of oxygen support therapy for those who needs invasive or non-invasive oxygen therapy will be documented	during hospital stay (Up to 28 days)

Collaborators and Investigators

• Sponsor: Ain Shams University
• Collaborators: Nasr City Insurance Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2021
• Primary Completion (Actual): July 30, 2022
• Study Completion (Actual): July 30, 2022

Study Registration Dates

• First Submitted: September 11, 2021
• First Submitted That Met QC Criteria: September 11, 2021
• First Posted (Actual): September 14, 2021

Study Record Updates

• Last Update Posted (Actual): August 25, 2023
• Last Update Submitted That Met QC Criteria: August 24, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Dermatologic Agents; Anti-Ulcer Agents; Anti-Allergic Agents; Histamine H1 Antagonists; Histamine Antagonists; Histamine Agents; Antipruritics; Histamine H1 Antagonists, Non-Sedating; Histamine H2 Antagonists; Famotidine; Loratadine
• Other Study ID Numbers: ACUCFPASURHDIRB2020110301REC43

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No