Ivermectin Nasal Spray for COVID19 Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04510233|
Recruitment Status : Not yet recruiting
First Posted : August 12, 2020
Last Update Posted : August 12, 2020
|Condition or disease||Intervention/treatment||Phase|
|Covid19||Drug: Ivermectin nasal Drug: Ivermectin oral Other: standard care||Phase 2|
Ivermectin is a well-known FDA-approved pan antiparasitic drug with high safety profile and potential therapeutic effects against COVID 19. It has been previously investigated as an antiviral agent. It showed 5000 fold reduction of SARS COV 2 viral RNA in-vitro studies.
However, some researchers questioned its efficacy in the oral form as very high doses will be required to achieve a proper tissue concentration and viricidal effect in the respiratory system.
Our hypothesis is that, since COVID-19 has shown to be particularly damaging to the respiratory system, using inhaled forms of Ivermectin will deliver the drug directly to the infection site and make it a treatment option.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Ivermectin Inhalation Forms in the Management of COVID-19 Egyptian Patients|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||October 2020|
|Estimated Study Completion Date :||December 2020|
Experimental: Ivermectin nasal spray
Ivermectin administered as nasal spray (one ml in each nostril two times daily)
Drug: Ivermectin nasal
Ivermectin nasal spray one ml in each nostril two times daily
Other Name: ivermectin
Experimental: Ivermectin oral
Ivermectin administered orally (one tablet 6 mg three times daily) for 72 hours plus the standard care of COVID-19 cases.
Drug: Ivermectin oral
Ivermectin oral (one tablet 6 mg three times daily)
Other Name: ivermectin
Experimental: standard care
COVID-19 cases will receive standard of care [oxygen via masks or ventilators]
Other: standard care
oxygen via masks or ventilators
- PCR of SARS-Cov2 RNA [ Time Frame: 14 days ]Negative PCR result of SARS-Cov2 RNA in COVID19 patients
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04510233
|Contact: Kamal Okasha, PhDemail@example.com|
|Contact: Nahla El-Ashmawy, PhDfirstname.lastname@example.org|
|Principal Investigator:||Kamal Okasha, PhD||Tanta Univesity faculty of Medicine|