Combined Antihistaminics Therapy in COVID 19 Patients
Primary Purpose
Covid19
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Loratadine
Famotidine
Sponsored by
About this trial
This is an interventional treatment trial for Covid19
Eligibility Criteria
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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).
Sites / Locations
- Nasr City Insurance Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Interventional group
Control group
Arm Description
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.
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)
Outcomes
Primary Outcome Measures
Assessment of number of patients who will need Mechanical ventillation
Assessment of the number of patients who will need vasopressor due to progression to shock
Secondary Outcome Measures
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
Full Information
NCT ID
NCT05043350
First Posted
September 11, 2021
Last Updated
August 24, 2023
Sponsor
Ain Shams University
Collaborators
Nasr City Insurance Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05043350
Brief Title
Combined Antihistaminics Therapy in COVID 19 Patients
Official Title
Potential Therapeutic Outcome of Combined Antihistaminics Therapy in COVID 19 Patients
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
September 13, 2021 (Actual)
Primary Completion Date
July 30, 2022 (Actual)
Study Completion Date
July 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ain Shams University
Collaborators
Nasr City Insurance Hospital
4. Oversight
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
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
214 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
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)
Intervention Type
Drug
Intervention Name(s)
Loratadine
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Famotidine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assessment of number of patients who will need Mechanical ventillation
Time Frame
during hospital stay (Up to 28 days)
Title
Assessment of the number of patients who will need vasopressor due to progression to shock
Time Frame
during hospital stay (Up to 28 days)
Secondary Outcome Measure Information:
Title
Assessment of Duration (number of days) the patients will need oxygen support therapy
Description
the duration of oxygen support therapy for those who needs invasive or non-invasive oxygen therapy will be documented
Time Frame
during hospital stay (Up to 28 days)
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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)
Exclusion Criteria:
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).
Facility Information:
Facility Name
Nasr City Insurance Hospital
City
Cairo
ZIP/Postal Code
11765
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Combined Antihistaminics Therapy in COVID 19 Patients
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