Covid protocol
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COVID-19 Protocols: A Comprehensive Overview
Clinical Trials for COVID-19 Treatments
DisCoVeRy Trial: Evaluating Re-purposed Therapeutics
The DisCoVeRy trial, initiated by the French National Institute for Health and Medical Research (Inserm), is a multicenter, adaptive, randomized controlled trial aimed at evaluating the safety and efficacy of various re-purposed antiviral agents in hospitalized COVID-19 patients. The trial includes five arms: a control group receiving Standard of Care (SoC) and four therapeutic arms with remdesivir, lopinavir/ritonavir, lopinavir/ritonavir with interferon (IFN)-β-1a, and hydroxychloroquine, all combined with SoC. The primary endpoint is the clinical status at Day 15 on the WHO 7-point ordinal scale1.
Convalescent Plasma Therapy
The ConPlas-19 study is a phase 2 randomized, open-label, controlled trial designed to assess the efficacy and safety of convalescent plasma (CP) in adult patients with severe COVID-19 pneumonia. Patients are randomized to receive either CP plus SoC or SoC alone, with the primary endpoint being the progression to severe disease categories on the WHO ordinal scale at Day 154.
TOGETHER Trial: Outpatient Treatments
The TOGETHER Trial is an international, multi-center, adaptive randomized controlled trial evaluating the efficacy of various re-purposed drugs for early COVID-19 treatment in high-risk outpatients. The primary endpoint is hospitalization or prolonged emergency room observation due to clinical worsening of COVID-195.
AGILE-ACCORD: Dose Optimization and Efficacy
The AGILE-ACCORD trial is a Bayesian, multi-arm, multi-dose, adaptive phase I/II platform trial aimed at determining the optimal dose, safety, and efficacy of multiple candidate agents for COVID-19 treatment. The trial includes both severe and mild-moderate COVID-19 patients and uses a seamless transition from phase I to phase II to assess efficacy6.
TICO/ACTIV-3: Antiviral Agents for Inpatients
The TICO/ACTIV-3 trial is a multi-arm, multi-stage platform protocol designed to rapidly evaluate the safety and efficacy of novel antiviral agents in hospitalized COVID-19 patients. The trial employs a robust approach to futility and safety evaluation, enabling rapid recruitment and assessment of multiple agents9.
Vaccination Protocols
Safe Vaccination for High-Risk Allergic Patients
A study developed a protocol for safely vaccinating patients with a high risk of allergic reactions to COVID-19 vaccines. The protocol includes skin prick tests (SPT), intradermal testing (IDT), and desensitization procedures. The study found that 99% of high-risk patients could be safely vaccinated using this protocol, even those with positive skin tests2.
Psychological Interventions for Healthcare Workers
E-Health Psychological Support
An online multi-component psychological intervention, "Personal COVID," was developed for healthcare workers in Mexico to address anxiety, depression, burnout, and compassion fatigue. The intervention includes nine core and three complementary modules aimed at improving mental health and quality of life3.
Long COVID and Mental Health
Systematic Review of Mental Health Interventions
A systematic review protocol aims to evaluate the effectiveness of interventions targeting mental health, cognition, or psychological well-being among individuals with long COVID. The review will synthesize data from clinical trials to inform future research and clinical practice7.
Impact on Workers
Another systematic review protocol focuses on the long-term effects of COVID-19 on workers, including the impact on their health status and professional life. This review will provide evidence to support health surveillance and decision-making for long-term COVID-19 management8.
Monoclonal Antibody Triage Protocol
Triage for Monoclonal Antibodies
A retrospective cohort study evaluated a triage protocol for prioritizing monoclonal antibody (mAb) therapy in COVID-19 patients. The protocol effectively differentiated patients by risk, optimizing the benefit in reducing hospitalization rates. The study also found no significant difference in hospitalization rates between subcutaneous and intravenous administration of mAbs10.
Conclusion
The ongoing research and trials on COVID-19 protocols highlight the collaborative efforts to find effective treatments, ensure safe vaccination, and address the mental health impacts of the pandemic. These studies provide valuable insights and pave the way for improved clinical practices and patient outcomes.
Sources and full results
Most relevant research papers on this topic
Protocol for the DisCoVeRy trial: multicentre, adaptive, randomised trial of the safety and efficacy of treatments for COVID-19 in hospitalised adults
The DisCoVeRy trial aims to evaluate the clinical efficacy and safety of re-purposed antiviral agents compared to Standard of Care in hospitalized COVID-19 patients.
RCT
Large Human Trial
Rigorous JournalProtocol of safe vaccination against COVID‐19 in patients with high risk of allergic reactions
This study developed a safe vaccination protocol for high-allergy-risk patients, enabling vaccination even in cases of positive skin tests.
Observational StudyE-Health Psychological Intervention for COVID-19 Healthcare Workers: Protocol for its Implementation and Evaluation
The "Personal COVID" online psychological intervention is expected to be highly effective in reducing emotional distress and promoting health for healthcare workers during the COVID-19 pandemic in Mexico.
RCTRigorous JournalEvaluation of convalescent plasma versus standard of care for the treatment of COVID-19 in hospitalized patients: study protocol for a phase 2 randomized, open-label, controlled, multicenter trial
Convalescent plasma may be an effective and safe treatment for adult patients with severe COVID-19 pneumonia, as demonstrated in a phase 2 randomized, open-label, controlled trial.
RCT
Very Rigorous JournalA multi-center, adaptive, randomized, platform trial to evaluate the effect of repurposed medicines in outpatients with early coronavirus disease 2019 (COVID-19) and high-risk for complications: the TOGETHER master trial protocol
The TOGETHER Trial aims to identify effective and affordable outpatient treatments for early COVID-19 in outpatients at high risk for severe complications, using repurposed drugs.
RCTAGILE-ACCORD: A Randomized, Multicentre, Seamless, Adaptive Phase I/II Platform Study to Determine the Optimal Dose, Safety and Efficacy of Multiple Candidate Agents for the Treatment of COVID-19: A structured summary of a study protocol for a randomised platform trial
AGILE-ACCORD is a multicentre, multi-dose, multi-stage, adaptive platform trial to determine the optimal dose, activity, and safety of multiple candidate agents for COVID-19 treatment.
RCTVery Rigorous JournalProtocol for a systematic review of interventions targeting mental health, cognition or psychological well-being among individuals with long COVID
This systematic review aims to evaluate the effectiveness of interventions promoting mental health, cognition, or psychological well-being among individuals with long COVID.
Systematic ReviewRigorous JournalImpact of long-term COVID on workers: A systematic review protocol
Long-term COVID-19 infection can negatively impact workers' health, quality of life, and professional life, requiring health surveillance and decision-making support.
Systematic ReviewRigorous JournalDesign and implementation of an international, multi-arm, multi-stage platform master protocol for trials of novel SARS-CoV-2 antiviral agents: Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3)
The Therapeutics for Inpatients with COVID-19 (TICO/ACTIV-3) protocol successfully enables rapid evaluation of safety and efficacy of novel antiviral agents for adults hospitalized with COVID-19.
Observational StudyPerformance of a Triage Protocol for Monoclonal Antibodies in a Mixed Vaccinated and Unvaccinated Cohort of COVID-19 Patients Treated With Intravenous Infusion or Subcutaneous Injection
Triaging mAbs for COVID-19 patients by risk can optimize benefits in reducing hospitalization rates, with rates of hospitalization potentially being similar between subcutaneous and intravenous administration.
Observational StudyRigorous Journal