isotretinoin / Kafrelsheikh University - LARVOL DELTA

Isotretinoin and Diabetes: Of Familiarity and Surprise (Medscape) - "'One of my patients took isotretinoin and instead of just needing metformin for their diabetes, it got so bad they needed insulin.'"

Media quote

Investigating the Potential Role of Aerosolized Retinoic Acid, a Potent Vitamin A Metabolite for Treating COVID-19 Anosmia and Retinoic Acid Insufficiency .A Novel Approach for Regaining Sense of Smell. (clinicaltrials.gov) - P4; N=10000; Not yet recruiting; Sponsor: Kafrelsheikh University; N=1000 ➔ 10000

Enrollment change • Infectious Disease • Novel Coronavirus Disease • IL6

Utilizing the Crosstalk Among Chicoric Acid, 13-Cis Retinoic Acid(Aerosolized), Minocycline and Vitamin D as a Potent Quadrate Therapy for Treating Patients With Multidrug-resistant TB and Patient With Both Multidrug-resistant TB and COVID-19 (clinicaltrials.gov) - P2; N=250; Not yet recruiting; Sponsor: Kafrelsheikh University

Clinical • New P2 trial • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8 • FOXP3 • IFNG • IL10 • IL2RA • IL6 • TGFB1 • TNFA

Dermatologists' Knowledge and Attitude Toward Isotretinoin Ocular Side Effects in Egypt. (PubMed, Clin Cosmet Investig Dermatol) - "As well, we found that the academic degree of dermatologists is directly proportional with warning patients about ocular side effects (p=0.003) and refractive surgery (p=0.039). Egyptian dermatologists were knowledgeable about the effects of isotretinoin on eyes with inappropriate clinical practice."

Adverse events • Journal • Acne Vulgaris • Dermatology • Dry Eye Disease • Keratitis • Ocular Inflammation • Ophthalmology

Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 ( Isotretinoin in Treatment of COVID-19) (Randomized) (clinicaltrials.gov) - P3; N=100000; Not yet recruiting; Sponsor: Kafrelsheikh University; Trial completion date: Jul 2021 ➔ Nov 2021; Trial primary completion date: Jun 2021 ➔ Oct 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • ANGPT1 • CD4 • CD8 • FOXP3 • IFIH1 • IL2RA • IL6 • TLR3

Combination Therapy With Isotretinoin and Tamoxifen Expected to Provide Complete Protection Against Severe Acute Respiratory Syndrome Coronavirus (clinicaltrials.gov) - P2; N=160; Not yet recruiting; Sponsor: Kafrelsheikh University; Trial completion date: Sep 2020 ➔ Dec 2021; Trial primary completion date: Aug 2020 ➔ Oct 2021

Combination therapy • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • IL6

Combination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising Treatment for COVID-19 Infection- and Its Inflammatory Complications (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Kafrelsheikh University; Trial completion date: Dec 2020 ➔ Oct 2021; Trial primary completion date: Nov 2020 ➔ Aug 2021

Trial completion date • Trial primary completion date • Congestive Heart Failure • Infectious Disease • Novel Coronavirus Disease • ANGPT1 • CRP • IL6 • PAI1 • TNFA • TNFRSF1B

Isotretinoin: Investigating the Role of 13cis Retinoic Acid in the Treatment of COVID-19 and Enhancement of Its Spike Protein Based Vaccine Efficacy and Safety. (clinicaltrials.gov) - P1/2; N=360; Not yet recruiting; Sponsor: Kafrelsheikh University; Initiation date: Feb 2021 ➔ Jul 2021; Trial primary completion date: Apr 2021 ➔ Sep 2021

Clinical • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • FOXP3 • IL2RA • TLR3

Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 ( Isotretinoin in Treatment of COVID-19) (Randomized) (clinicaltrials.gov) - P3; N=100000; Not yet recruiting; Sponsor: Kafrelsheikh University; Trial completion date: Mar 2021 ➔ Jul 2021; Trial primary completion date: Feb 2021 ➔ Jun 2021

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • ANGPT1 • CD4 • CD8 • FOXP3 • IFIH1 • IL2RA • IL6

Isotretinoin (13- Cis-Retinoic Acid) Versus Spike Protein Based Vaccine for Providing Complete Protection Against COVID-19 and Preventing the Expected Long Term Serious Side Effects Which May Caused by Spike Protein Based Vaccine-An Urgent Protective Clinical Trial (clinicaltrials.gov) - P1/2; N=360; Not yet recruiting; Sponsor: Kafrelsheikh University; Trial completion date: Sep 2021 ➔ Dec 2023

Adverse events • Clinical • Trial completion date • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • FOXP3 • IL2RA

Assessment the Activity Value of Isotretinoin (13- Cis-Retinoic Acid ) in the Treatment of COVID-19 ( Isotretinoin in Treatment of COVID-19) (Randomized) (clinicaltrials.gov) - P3; N=100000; Not yet recruiting; Sponsor: Kafrelsheikh University; N=1000 ➔ 100000; Trial completion date: Dec 2020 ➔ Mar 2021; Initiation date: Oct 2020 ➔ Feb 2021; Trial primary completion date: Nov 2020 ➔ Feb 2021

Clinical • Enrollment change • Trial completion date • Trial initiation date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • ANGPT1 • CD4 • CD8 • FOXP3 • IFIH1 • IL2RA • IL6

Isotretinoin (13- Cis-Retinoic Acid) Versus Spike Protein Based Vaccine for Providing Complete Protection Against COVID-19 and Preventing the Expected Long Term Serious Side Effects Caused by Spike Protein Based Vaccine (clinicaltrials.gov) - P1/2; N=360; Not yet recruiting; Sponsor: Kafrelsheikh University

Adverse events • New P1/2 trial • Infectious Disease • Novel Coronavirus Disease • CD4 • CD8 • FOXP3 • IL2RA

Efficacy and Safety of Drug Combination Therapy of Isotretinoin and Some Antifungal Drugs as A Potential Aerosol Therapy for COVID-19 : An Innovative Therapeutic Approach COVID-19 (clinicaltrials.gov) - P2; N=45; Not yet recruiting; Sponsor: Kafrelsheikh University

Clinical • Combination therapy • New P2 trial • Infectious Disease • Novel Coronavirus Disease • IL6

Combination With All-trans Retinoic Acid and Isotretinoin as A Novel Treatment for Inducing Neutralizing Antibodies in COVID-19 Infected Patients Better Than Vaccine: An Innovative Treatment (clinicaltrials.gov) - P2; N=360; Not yet recruiting; Sponsor: Kafrelsheikh University; Initiation date: Jun 2020 ➔ Oct 2020

Clinical • Trial initiation date • Infectious Disease • Novel Coronavirus Disease • IL6

Assessment the Activity Value of 13- Cis-Retinoic Acid (Isotretinoin) in the Treatment of COVID-19 (Randomized) (clinicaltrials.gov) - P3; N=1000; Not yet recruiting; Sponsor: Kafrelsheikh University; Trial completion date: Aug 2020 ➔ Nov 2020

Clinical • Trial completion date • Infectious Disease • Novel Coronavirus Disease • Ophthalmology

Assessment the Activity Value of 13- Cis-Retinoic Acid (Isotretinoin) in the Treatment of COVID-19 (Randomized) (clinicaltrials.gov) - P3; N=1000; Not yet recruiting; Sponsor: Kafrelsheikh University; Phase classification: P2/3 ➔ P3; N=360 ➔ 1000

Clinical • Enrollment change • Phase classification • Infectious Disease • Novel Coronavirus Disease • Ophthalmology

Combination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2 (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Kafrelsheikh University; Trial completion date: Sep 2020 ➔ Dec 2020; Trial primary completion date: Jul 2020 ➔ Nov 2020

Trial completion date • Trial primary completion date • Congestive Heart Failure • Infectious Disease • Novel Coronavirus Disease • Ophthalmology • ANGPT1 • CRP • IL6 • PAI1 • TNFA • TNFRSF1B

Combination Therapy With Isotretinoin and Tamoxifen May Provide Complete Protection Against Severe Acute Respiratory Syndrome Coronavirus (clinicaltrials.gov) - P2; N=160; Not yet recruiting; Sponsor: Kafrelsheikh University

Combination therapy • New P2 trial • Novel Coronavirus Disease • Ophthalmology • IL6

Combination With Alvelestat and Isotretinoin May Enhances Neutralizing Antibodies in COVID -19 Infected Patients Better Than COVID-19 Inactivated Vaccines (clinicaltrials.gov) - P2; N=360; Not yet recruiting; Sponsor: Kafrelsheikh University

Clinical • New P2 trial • Novel Coronavirus Disease • Ophthalmology

Assessment the Activity Value of 13- Cis-Retinoic Acid (Isotretinoin) in the Treatment of COVID-19 (Randomized) (clinicaltrials.gov) - P2/3; N=360; Not yet recruiting; Sponsor: Kafrelsheikh University; Phase classification: P3 ➔ P2/3; N=45 ➔ 360

Clinical • Enrollment change • Phase classification • Novel Coronavirus Disease • Ophthalmology • IL6

Combination of Recombinant Bacterial ACE2 Receptors -Like Enzyme of B38-CAP and Isotretinoin Could be Promising COVID-19 Infection- and Lung Injury Preventing Drug Better Than Recombinant Human ACE2 (clinicaltrials.gov) - P1; N=24; Not yet recruiting; Sponsor: Kafrelsheikh University

New P1 trial • Cardiovascular • Congestive Heart Failure • Heart Failure • Infectious Disease • Novel Coronavirus Disease • Ophthalmology • ANGPT1 • CRP • IL6 • PAI1 (Plasminogen Activator Inhibitor 1) • TNFA • TNFRSF1B