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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Sep 2021

Typical duration for phase_2 covid19

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 11, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

September 13, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 14, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 30, 2022

Completed
Last Updated

August 25, 2023

Status Verified

August 1, 2023

Enrollment Period

11 months

First QC Date

September 11, 2021

Last Update Submit

August 24, 2023

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • Assessment of Duration (number of days) the patients will need oxygen support therapy

    during hospital stay (Up to 28 days)

Study Arms (2)

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.

Drug: LoratadineDrug: 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)

Drug: Famotidine

Interventions

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.

Interventional group
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.

Control groupInterventional group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nasr City Insurance Hospital

Cairo, 11765, Egypt

Location

MeSH Terms

Conditions

COVID-19

Interventions

LoratadineFamotidine

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

CyproheptadineDibenzocycloheptenesBenzocycloheptenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPolycyclic CompoundsThiazolesSulfur CompoundsAzoles

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Pharmacology & Toxicology

Study Record Dates

First Submitted

September 11, 2021

First Posted

September 14, 2021

Study Start

September 13, 2021

Primary Completion

July 30, 2022

Study Completion

July 30, 2022

Last Updated

August 25, 2023

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)