Study to Evaluate the Efficacy of COVID19-0001-USR in Patients With Mild/or Moderate COVID-19 Infection in Outpatient

SARS-CoV-2 Infection Clinical Trial

— COVID-19  

Official title:

A Two-arm Randomized Double-blind Study With COVID19-0001-USR Administered Via Nebulization to Patients With Mild and/or Moderate Severe Acute Respiratory Syndrome (SARS-COV-2) Infection to Decrease Viral Load

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04595136
• Other study ID #: COVID19-0001-USR
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: November 2, 2020
• Est. completion date: August 30, 2021

Study information

• Verified date: May 2021
• Source: United Medical Specialties
• Contact: Carlos A Riveros, MD
• Phone: 305-224-2201
• Email: Carlosrivg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Determine the efficacy and safety of COVID19-0001-USR in the treatment of SARS-COV-2 infection in mild to moderate manifestations administered via nebulization/inhalation.

Description:

This is an interventional, randomized controlled, double-blind study (i.e., active and passive control), 1 intervention group will be randomized with COVID 19-001-USR, and a control group to receive a placebo intervention to assess efficacy, tolerance, and decrease viral load and clinical manifestation on patients infected with SARS-COV-2. This will be a self-administered study drug 3 times a day for 7 days

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: August 30, 2021
• Est. primary completion date: July 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Provide written consent before being included in the essay.

• Positive cases of COVID-19 (based on polymerase chain reaction or positive antigen test for SARS-CoV-2),

• Being diagnosed with mild to moderate SARS-COV-2 disease (COVID19)

• Symptomatic or asymptomatic patient, with good clinical appearance, Sat O2 at rest > 94% with room air, and without desaturation with ambulation, and without tachypnea,

• Respiratory rate < 20.

• Suspected cases of COVID-19, based on 3 criteria:

• Fever > 38 Degrees Celsius

• O2 saturation =94

• Abnormal laboratory indicators, any of them:

• Lymphopenia <1500 cells/m3

• C reactive protein >2 mg/L

• Ferritin >300g/L

Exclusion Criteria:

• Existing decompensated conditions such as Diabetes Mellitus, Hypertension, Coronary Insufficiency, Coronary Artery Disease, Chronic Obstructive Pulmonary Disease (or any chronic or severe lung disease), Chronic Kidney Disease, Cancer, Immunosuppression, Mood Change

• Respiratory Frequency > 20 / min, Pulse > 120 bpm, systolic < 90 mmHg, diastolic < 60 mmHg

• The patient seems toxic and distressed, or, O2 at rest <93% in ambient air, or desaturation when ambulating

• Being diagnosed with severe SARS-COV-2 disease (COVID19)

• Patients with low oxygen saturation levels, need for ICU entry, need or likelihood of invasive mechanical ventilation

• Patients requiring bronchodilator treatment

• Patients with a known history of asthma and/or lung disease

• Patients with severe decompensated Chronic Obstructive Pulmonary Disease

• Patients who are unable to give consent or who are unable to follow up on the test group will be excluded

Related Conditions & MeSH terms

• Communicable Diseases
• Infection
• SARS-CoV-2 Infection

Intervention

Drug:
• Drug COVID19-0001-USR
COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2
• normal saline
0.9% NS via nebulization

Locations

Country	Name	City	State
Colombia	Cimedical	Barranquilla	Atlantico

Sponsors (1)

Lead Sponsor	Collaborator
United Medical Specialties

Country where clinical trial is conducted

Colombia, 

References & Publications (9)

Chan JF, Yip CC, To KK, Tang TH, Wong SC, Leung KH, Fung AY, Ng AC, Zou Z, Tsoi HW, Choi GK, Tam AR, Cheng VC, Chan KH, Tsang OT, Yuen KY. Improved Molecular Diagnosis of COVID-19 by the Novel, Highly Sensitive and Specific COVID-19-RdRp/Hel Real-Time Reverse Transcription-PCR Assay Validated In Vitro and with Clinical Specimens. J Clin Microbiol. 2020 Apr 23;58(5). pii: e00310-20. doi: 10.1128/JCM.00310-20. Print 2020 Apr 23. — View Citation

Mastrangelo E, Pezzullo M, De Burghgraeve T, Kaptein S, Pastorino B, Dallmeier K, de Lamballerie X, Neyts J, Hanson AM, Frick DN, Bolognesi M, Milani M. Ivermectin is a potent inhibitor of flavivirus replication specifically targeting NS3 helicase activity: new prospects for an old drug. J Antimicrob Chemother. 2012 Aug;67(8):1884-94. doi: 10.1093/jac/dks147. Epub 2012 Apr 25. — View Citation

Mitjà O, Clotet B. Use of antiviral drugs to reduce COVID-19 transmission. Lancet Glob Health. 2020 May;8(5):e639-e640. doi: 10.1016/S2214-109X(20)30114-5. Epub 2020 Mar 19. — View Citation

Peña-Silva R, Duffull SB, Steer AC, Jaramillo-Rincon SX, Gwee A, Zhu X. Pharmacokinetic considerations on the repurposing of ivermectin for treatment of COVID-19. Br J Clin Pharmacol. 2021 Mar;87(3):1589-1590. doi: 10.1111/bcp.14476. Epub 2020 Jul 17. — View Citation

Wagstaff KM, Sivakumaran H, Heaton SM, Harrich D, Jans DA. Ivermectin is a specific inhibitor of importin a/ß-mediated nuclear import able to inhibit replication of HIV-1 and dengue virus. Biochem J. 2012 May 1;443(3):851-6. doi: 10.1042/BJ20120150. — View Citation

Yang SNY, Atkinson SC, Wang C, Lee A, Bogoyevitch MA, Borg NA, Jans DA. The broad spectrum antiviral ivermectin targets the host nuclear transport importin a/ß1 heterodimer. Antiviral Res. 2020 May;177:104760. doi: 10.1016/j.antiviral.2020.104760. Epub 2020 Mar 3. — View Citation

Zhao J, Yuan Q, Wang H, Liu W, Liao X, Su Y, Wang X, Yuan J, Li T, Li J, Qian S, Hong C, Wang F, Liu Y, Wang Z, He Q, Li Z, He B, Zhang T, Fu Y, Ge S, Liu L, Zhang J, Xia N, Zhang Z. Antibody Responses to SARS-CoV-2 in Patients With Novel Coronavirus Disease 2019. Clin Infect Dis. 2020 Nov 19;71(16):2027-2034. doi: 10.1093/cid/ciaa344. — View Citation

Zheng S, Fan J, Yu F, Feng B, Lou B, Zou Q, Xie G, Lin S, Wang R, Yang X, Chen W, Wang Q, Zhang D, Liu Y, Gong R, Ma Z, Lu S, Xiao Y, Gu Y, Zhang J, Yao H, Xu K, Lu X, Wei G, Zhou J, Fang Q, Cai H, Qiu Y, Sheng J, Chen Y, Liang T. Viral load dynamics and disease severity in patients infected with SARS-CoV-2 in Zhejiang province, China, January-March 2020: retrospective cohort study. BMJ. 2020 Apr 21;369:m1443. doi: 10.1136/bmj.m1443. — View Citation

Zou L, Ruan F, Huang M, Liang L, Huang H, Hong Z, Yu J, Kang M, Song Y, Xia J, Guo Q, Song T, He J, Yen HL, Peiris M, Wu J. SARS-CoV-2 Viral Load in Upper Respiratory Specimens of Infected Patients. N Engl J Med. 2020 Mar 19;382(12):1177-1179. doi: 10.1056/NEJMc2001737. Epub 2020 Feb 19. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change on viral load results from baseline after using COVID19-0001-USR via nebulization	COVID19-0001-USR 1% nebulized pathway changes viral load of SARS-COV-2 virus (COVID19) in the upper and lower airways if started during the initial phase of infection	Treatment Period of 7 days

External Links

•   Nebulized ivermectin for COVID-19 and other respiratory diseases, a proof of concept, dose-ranging study in rats