Covid19Phase 2/3NCT05043350
Combined Antihistaminics Therapy in COVID 19 Patients
A Phase 2/3 study testing Loratadine and Famotidine in people with Covid19, run by Ain Shams University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Covid19
- What is being tested?
- Loratadine and Famotidine
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Sep 2021to 30 Jul 2022
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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
- Conditions
- Covid19
- Being tested
- Loratadine, Famotidine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LoratadineDrug
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.
FamotidineDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Loratadine; Drug: Famotidine |
| 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) Receives: Drug: Famotidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of number of patients who will need Mechanical ventillation
Measured: during hospital stay (Up to 28 days)
Assessment of the number of patients who will need vasopressor due to progression to shock
Measured: during hospital stay (Up to 28 days)
Secondary outcomes (1)
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
Measured: during hospital stay (Up to 28 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2021
- Study start13 Sep 2021
- Primary completion30 Jul 2022
- Study completion30 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Ain Shams UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Collaborators
- Nasr City Insurance Hospital
- Responsible party
- Principal investigator, Samar Saad elDeen Azab, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05043350
- Sponsor's protocol ID
- ACUCFPASURHDIRB2020110301REC43
- Status last verified
- Aug 2023
- First submitted
- 11 Sep 2021
- Last updated
- 25 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Potential Therapeutic Outcome of Combined Antihistaminics Therapy in COVID 19 Patients
- ClinicalTrials.gov ID
- NCT05043350
- Acronym / sponsor ID
- ACUCFPASURHDIRB2020110301REC43
- Conditions
- Covid19
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Collaborators
- Nasr City Insurance Hospital
- Study start
- 13 Sep 2021 (actual)
- Primary completion
- 30 Jul 2022 (actual)
- Study completion
- 30 Jul 2022 (actual)
- First posted
- 14 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Drug: Loratadine, Drug: Famotidine107 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. |
| Control group | Active comparator | Drug: Famotidine107 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) |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Loratadine107 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 | Interventional group |
| Famotidine107 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 | Control group, Interventional group |
Primary outcome
Assessment of number of patients who will need Mechanical ventillation
Time frame: during hospital stay (Up to 28 days)
Assessment of the number of patients who will need vasopressor due to progression to shock
Time frame: during hospital stay (Up to 28 days)
1 secondary outcome
Assessment of Duration (number of days) the patients will need oxygen support therapy
Time frame: during hospital stay (Up to 28 days)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2023.
- Individual participant dataSharing planned: No
Related trials for Covid19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Loratadine and Famotidine in people with Covid19, run by Ain Shams University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of number of patients who will need Mechanical ventillation (time frame: during hospital stay (Up to 28 days)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2023.