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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| COVID19-0001-USR | Experimental | Group 1 Patients with SARS-COV-2 (COVID19) positive test will receive Investigational Drug administer by nebulization ( COVID-19-0001-USR) Dosage: 3ml Frequency and Duration: Three times a day for 7 days |
|
| Normal Saline | Placebo Comparator | Group 2 of patients with positive tests intervention SARS-COV-2 (COVID19) with placebo (i.e., normal saline 0.9% NS) plus standard baseline treatment for covid provided by Primary care provider ( Azithromycin, dexamethasone, and/or anticoagulants) Dosage: 3ml Frequency and Duration: Three times a day for 7 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Drug COVID19-0001-USR | Drug | COVID19-0001-USR by nebulization for patients with mild and/or moderate SARS- COV-2 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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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:
Abnormal laboratory indicators, any of them:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carlos A Riveros, MD | Contact | 305-224-2201 | Carlosrivg@gmail.com | |
| Juan Jaller, MD | Contact | 57-310-630-3530 | juanjaller@cimedical.co |
| Name | Affiliation | Role |
|---|---|---|
| Juan Jaller, MD | United Medical Specialties | Principal Investigator |
| Carlos A Riveros, MD | United Medical Specialties | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cimedical | Recruiting | Barranquilla | Atlántico | Colombia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32779815 | Background | Pena-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. No abstract available. | |
| 32132196 | Background | 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):e00310-20. doi: 10.1128/JCM.00310-20. Print 2020 Apr 23. |
| Label | URL |
|---|---|
| Nebulized ivermectin for COVID-19 and other respiratory diseases, a proof of concept, dose-ranging study in rats | View source |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D018352 | Coronavirus Infections |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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Interventional study, randomized controlled, double-blind (i.e., active and passive control), 1 intervention group with investigative medicine, and a control group that will receive placebo intervention.
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The mapping sequence will be hidden from the researcher by enrolling and evaluating participants in sequentially numbered, sealed, and stapled envelopes. To avoid the subversion of the allocation sequence, the name and date of birth of the participant will be written in the envelope, a second researcher verifies the process. The corresponding envelopes will be opened only after the enrolled participants complete all the reference assessments and assignment of the intervention by the protocol
| normal saline | Drug | 0.9% NS via nebulization |
|
|
| 32074444 | Background | 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. No abstract available. |
| 32317267 | Background | 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. |
| 32199468 | Background | Mitja 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. No abstract available. |
| 32221519 | Background | 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. |
| 22417684 | Background | Wagstaff KM, Sivakumaran H, Heaton SM, Harrich D, Jans DA. Ivermectin is a specific inhibitor of importin alpha/beta-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. |
| 22535622 | Background | 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. |
| 32135219 | Background | 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 alpha/beta1 heterodimer. Antiviral Res. 2020 May;177:104760. doi: 10.1016/j.antiviral.2020.104760. Epub 2020 Mar 3. |
| D014777 |
| Virus Diseases |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |