NCT04551755

Brief Summary

A randomized double blind control trial will be done. Total 188 Covid-19 patients will be enrolled in this trial who are RT-PCR confirmed case of mild cases. Before enrollment, base line investigations will be done and as per eligibility criteria 188 (one hundred eighty eight) patients of mild symptoms will be selected by random sampling. Ninety four diagnosed patients (Group-A) of Covid-19 will be in the experimental group and 94 Covid-19 diagnosed patients (Group-B) will be in the control group. Group -A will be given combination treatment of Tab Ivermectin and Cap Doxycycline along with standard therapy and Group -B will be treated by standard therapy with placebo. Follow up will be done every day in both group with all the parameters as stated above and will be documented. On 5th day of treatment, if fever subsides final outcome will be measured by result of RT-PCR test preferably from one designated lab with sample of nasal swab for all. Subject to RT-PCR test negative result again on 6th day another RT-PCR test will be done at 24 hours apart. But if RT-PCR test result remain positive on 5th day, again on 10th day same test is to be done and also on 11th day subject to test result as negative on 10th day. Death of the patients will be documented as well. Regarding safety issues of the drugs we shall monitor for any SAE and would report to the DSMB for proper management guideline

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P50-P75 for phase_2 covid19

Timeline
Completed

Started Sep 2020

Shorter than P25 for phase_2 covid19

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2020

Completed
13 days until next milestone

First Posted

Study publicly available on registry

September 16, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

September 16, 2020

Status Verified

July 1, 2020

Enrollment Period

2 months

First QC Date

September 3, 2020

Last Update Submit

September 15, 2020

Conditions

Covid19

Outcome Measures

Primary Outcomes (2)

  • Time to outcome measure of fever (<100.40F)and cough

    Outcome measure of symptoms associated with covid, fever and cough

    10 days

  • Negative RT-PCR test on day 5 of treatment

    If the result of RT-PCR test is negative, then 24 hours apart another RT-PCR test will be done. Subject to 2 consecutive negative tests patient will be declared as cured

    10 days

Study Arms (2)

Ivermectin plus Doxycycline plus standard care

ACTIVE COMPARATOR

Tab Ivermectin (6mg): 12mg first dose then one more dose of 12mgafter 12 hours 2) Cap. Doxycycline (100mg): 1+0+1 after meal for 10 days. To be taken with half glass of water and sit up for 20 minutes 3) Standard symptomatic and supportive treatment; Tab paracetamol, tab antihistamine, tab montelukast will be mostly used as symptomatic treatment, vitamin C and vitamin D as supplements

Drug: Ivermectin and Doxycycline

Placebo plus standard care

PLACEBO COMPARATOR

1\) Standard symptomatic and supportive treatment with placebo; Standard treatment includes tab paracetamol, tab antihistamine, tab montelukast will be mostly used as symptomatic treatment, vitamin C and vitamin D as supplements. Placebo (1) 2 tab stat then again 2 tab after 12 hours Placebo (2) will be given as 1+0+1 for 10 days

Other: Placebo

Interventions

Ivermectin and DoxycyclineDRUG

1. Tab Ivermectin (6mg): 12mg first dose then one more dose of 12mgafter 12 hours 2. Cap. Doxycycline (100mg): 1+0+1 after meal for 10 days. To be taken with half glass of water and sit up for 20 minutes

Ivermectin plus Doxycycline plus standard care
PlaceboOTHER

Placebo (1) 2 tab stat then again 2 tab after 12 hours Placebo (2) will be given as 1+0+1 for 10 days

Placebo plus standard care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects within age group 18 years to onward
  • With either sex, male or female
  • Confirmed mild cases of Covid-19 by RT-PCR test
  • patients who are classified as mild cases with typical symptoms
  • patients who are not already treated with any other antiviral drugs

You may not qualify if:

  • Patients who are asymptomatic,moderate, severe and critically ill (resting respiratory rate more than 30, O2 saturation below 93%).
  • Patients with co-morbidities (diabetes, hypertension, chronic liver and kidney diseases obesity, pre-existing ischemic heart disease, COPD,other severe disease)
  • Patients with pregnancy and on lactation
  • Patients with previous allergic reaction to Ivermectin or Doxycycline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (14)

  • Beigel JH, Tomashek KM, Dodd LE, Mehta AK, Zingman BS, Kalil AC, Hohmann E, Chu HY, Luetkemeyer A, Kline S, Lopez de Castilla D, Finberg RW, Dierberg K, Tapson V, Hsieh L, Patterson TF, Paredes R, Sweeney DA, Short WR, Touloumi G, Lye DC, Ohmagari N, Oh MD, Ruiz-Palacios GM, Benfield T, Fatkenheuer G, Kortepeter MG, Atmar RL, Creech CB, Lundgren J, Babiker AG, Pett S, Neaton JD, Burgess TH, Bonnett T, Green M, Makowski M, Osinusi A, Nayak S, Lane HC; ACTT-1 Study Group Members. Remdesivir for the Treatment of Covid-19 - Final Report. N Engl J Med. 2020 Nov 5;383(19):1813-1826. doi: 10.1056/NEJMoa2007764. Epub 2020 Oct 8.

    PMID: 32445440BACKGROUND

  • Mehlhorn H (2008). Encyclopedia of parasitology (3rd ed.). Berlin: Springer. p. 646. ISBN 978-3-540-48994-8

    BACKGROUND

  • Vercruysse J, Rew RS, eds. (2002). Macrocyclic lactones in antiparasitic therapy. Oxon, UK: CABI Pub. p. Preface. ISBN 978-0-85199-840-4

    BACKGROUND

  • Azeem S, Ashraf M, Rasheed MA, Anjum AA, Hameed R. Evaluation of cytotoxicity and antiviral activity of ivermectin against Newcastle disease virus. Pak J Pharm Sci. 2015 Mar;28(2):597-602.

    PMID: 25730813BACKGROUND

  • 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.

    PMID: 22535622BACKGROUND

  • Gotz V, Magar L, Dornfeld D, Giese S, Pohlmann A, Hoper D, Kong BW, Jans DA, Beer M, Haller O, Schwemmle M. Influenza A viruses escape from MxA restriction at the expense of efficient nuclear vRNP import. Sci Rep. 2016 Mar 18;6:23138. doi: 10.1038/srep23138.

    PMID: 26988202BACKGROUND

  • Lundberg L, Pinkham C, Baer A, Amaya M, Narayanan A, Wagstaff KM, Jans DA, Kehn-Hall K. Nuclear import and export inhibitors alter capsid protein distribution in mammalian cells and reduce Venezuelan Equine Encephalitis Virus replication. Antiviral Res. 2013 Dec;100(3):662-72. doi: 10.1016/j.antiviral.2013.10.004. Epub 2013 Oct 22.

    PMID: 24161512BACKGROUND

  • Caly L, Druce JD, Catton MG, Jans DA, Wagstaff KM. The FDA-approved drug ivermectin inhibits the replication of SARS-CoV-2 in vitro. Antiviral Res. 2020 Jun;178:104787. doi: 10.1016/j.antiviral.2020.104787. Epub 2020 Apr 3.

    PMID: 32251768BACKGROUND

  • Choudhary R, Sharma AK. Potential use of hydroxychloroquine, ivermectin and azithromycin drugs in fighting COVID-19: trends, scope and relevance. New Microbes New Infect. 2020 Apr 22;35:100684. doi: 10.1016/j.nmni.2020.100684. eCollection 2020 May.

    PMID: 32322397BACKGROUND

  • Conforti C, Giuffrida R, Zalaudek I, Di Meo N. Doxycycline, a widely used antibiotic in dermatology with a possible anti-inflammatory action against IL-6 in COVID-19 outbreak. Dermatol Ther. 2020 Jul;33(4):e13437. doi: 10.1111/dth.13437. Epub 2020 May 15. No abstract available.

    PMID: 32314492BACKGROUND

  • Sodhi M, Etminan M. Therapeutic Potential for Tetracyclines in the Treatment of COVID-19. Pharmacotherapy. 2020 May;40(5):487-488. doi: 10.1002/phar.2395. Epub 2020 May 4. No abstract available.

    PMID: 32267566BACKGROUND

  • Mahevas M, Tran VT, Roumier M, Chabrol A, Paule R, Guillaud C, Fois E, Lepeule R, Szwebel TA, Lescure FX, Schlemmer F, Matignon M, Khellaf M, Crickx E, Terrier B, Morbieu C, Legendre P, Dang J, Schoindre Y, Pawlotsky JM, Michel M, Perrodeau E, Carlier N, Roche N, de Lastours V, Ourghanlian C, Kerneis S, Menager P, Mouthon L, Audureau E, Ravaud P, Godeau B, Gallien S, Costedoat-Chalumeau N. Clinical efficacy of hydroxychloroquine in patients with covid-19 pneumonia who require oxygen: observational comparative study using routine care data. BMJ. 2020 May 14;369:m1844. doi: 10.1136/bmj.m1844.

    PMID: 32409486BACKGROUND

  • Tang W, Cao Z, Han M, Wang Z, Chen J, Sun W, Wu Y, Xiao W, Liu S, Chen E, Chen W, Wang X, Yang J, Lin J, Zhao Q, Yan Y, Xie Z, Li D, Yang Y, Liu L, Qu J, Ning G, Shi G, Xie Q. Hydroxychloroquine in patients with mainly mild to moderate coronavirus disease 2019: open label, randomised controlled trial. BMJ. 2020 May 14;369:m1849. doi: 10.1136/bmj.m1849.

    PMID: 32409561BACKGROUND

  • Rosenberg ES, Dufort EM, Udo T, Wilberschied LA, Kumar J, Tesoriero J, Weinberg P, Kirkwood J, Muse A, DeHovitz J, Blog DS, Hutton B, Holtgrave DR, Zucker HA. Association of Treatment With Hydroxychloroquine or Azithromycin With In-Hospital Mortality in Patients With COVID-19 in New York State. JAMA. 2020 Jun 23;323(24):2493-2502. doi: 10.1001/jama.2020.8630.

    PMID: 32392282BACKGROUND

Related Links

MeSH Terms

Conditions

COVID-19

Interventions

IvermectinDoxycycline

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

MacrolidesPolyketidesLactonesOrganic ChemicalsTetracyclinesNaphthacenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsPolycyclic Compounds

Study Officials

  • Mohammad Tarek Alam, MD

    Bangladesh Medical College Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohammad Tarek Alam, MD

CONTACT

01819185449mtarekalam16@gmail.com

Abdul Basit Ibne Momen, MRCP

CONTACT

01674255082abdulbasit17@gmail.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 3, 2020

First Posted

September 16, 2020

Study Start

September 1, 2020

Primary Completion

November 1, 2020

Study Completion

December 1, 2020

Last Updated

September 16, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share