Clinical Trial of Ivermectin Plus Doxycycline for the Treatment of Confirmed Covid-19 Infection
Condition: Covid19
MeSH terms: COVID-19
Intervention: Ivermectin and Doxycycline; Standard of care
Intervention description: Ivermectin 6 mg, 2 tab stat and Doxycycline 100 mg twice daily for 5 days; Paracetamol, Vitamin D, Oxygen if indicated, Low molecular weight heparin, dexamethasone if indicated
Intervention MeSH terms: Doxycycline; Ivermectin
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patient will be randomized 1:1 to placaebo with standard care and combined doxycycline and ivermectin with standard care.
Masking: Double (Participant, Investigator)
Masking description: Double blind (The participant and the clinicians/data collectors will be unaware of the treatment the participant receives).The drugs will be labelled with a random code number
Enrollment: 400.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Covid-19, Ivermectin

Summary:

      On 31 December 2019, the World Health Organization (WHO) was formally notified about a
      cluster of cases of pneumonia in Wuhan City, China. On 7 January the responsible virus was
      isolated and its genome sequence was shared on 12 January. It was named as COVID-19, a novel
      Coronavirus, SARS-CoV-2. It is a member of the Corona virus family which is RNA enveloped
      viruses.

      Very rapidly the virus emerged as pandemic. Now it is dominating the lives of every people of
      this universe. Management of the COVID-19 relies on mainly supportive care and oxygen
      supplementation via non-invasive or mechanical ventilation in critical cases. Patients who
      are critically ill may also require vasopressor support and antibiotics for secondary
      bacterial infections.

      There is no vaccine or highly effective antiviral drugs for COVID-19. Currently there is a
      tremendous effort around the world to develop effective preventive and therapeutic treatment
      for this disease.

      World Health Organization has launched a non-blinded clinical trial (SOLIDARITY) to evaluate
      four candidate treatments (remdesivir, lopinavir/ritonavir, lopinavir/ritonavir/ interferon
      beta-1a, and chloroquine or hydroxychloroquine) versus standard of care in 18 countries
      worldwide. RECOVERY trial one of the largest trials to see the efficacy and safety of
      hydroxychloroquine revealed that they are no clear cut clinical benefit for COVID-19. Other
      drugs in the SOLIDARTY trial are quite expansive for resource limited countries like
      Bangladesh.

      Study Published in the American Journal of Tropical Medicine advocates further research into
      Ivermectin for COVID-19 Treatment. The spotlight on Ivermectin was brought by Australian
      researchers from Monash University who demonstrated its efficacy against the SARS-CoV-2
      coronavirus in vitro studies.

      In different study Doxycycline also showed promising results in treatment of COVID 19
      infection. It is highly lipophilic antibiotics that are known to chelate zinc component of
      matrix metalloprotienases (MMP). Corona viruses are known to rely heavily of MMPs for
      survival, cell infiltration and replication. It also has an anti-inflammatory effect which
      might be effective in combating cytokine storm of Covid-19 infection.

      So it have been planned to conduct an experimental clinical trial using combination of
      ivermectin and doxycycline for treatment of COVID 19 along with the other standard care.
    

Eligibility criteria:

        Inclusion Criteria:

          -  COVID-19 infection, confirmed by polymerase chain reaction (PCR) test within 3 days
             from enrollment

          -  Only mild and moderate COVID-19 infected cases

          -  Able to provide informed consent

        Exclusion Criteria:

          -  Unable to take oral medication

          -  Pregnant or breast feeding lady

          -  Patients with severe COVID symptoms or admission in ICU/HDU

          -  Alanine Aminotransferase (ALT) or aspartate aminotransferase (AST) more than 5 upper
             limit of normal (ULN)

          -  On non-invasive positive pressure ventilation or mechanical ventilation at time of
             study entry

          -  Known hypersensitivity to Doxycycline or ivermectin or its components.