Table 1.
Mode of Immunotherapy | Stages of the clinical trials (CT Registration No) | Number of patients enrolled | Current status | Evaluation/Results | Specificity |
---|---|---|---|---|---|
Convalescent plasma | 3 (NCT04372979) 2/3 (NCT04388410) ½ (NCT04384497) 1 (NCT04353206) |
80 410 50 50 |
Recruiting | Prevented secondary worsening and reduced the risk to be transferred to intensive care, length of stay and mortality, decreased duration of oxygen therapy, cleared viremia/SARS-CoV-2, decreased duration of symptoms, inflammatory mediators, increased antibody response to SARS-CoV-2 |
Specific to COVID-19 |
Monoclonal Ab | NCT04354766 | 10 | Recruiting | Comparing the serological profiles and neutralizing efficiency of plasma to the neutralizing capacities of the monoclonal antibodies generated with immortalized B cells. | Specific to COVID-19 |
Immunoglobulin (IVIG) | 4 (NCT04411667) 3 (NCT04350580) 2/3 (NCT04261426) 2 (NCT04432324) ½ (NCT04521309) |
34 138 80 100 50 |
Not recruiting rest all recruiting | Clinical signs, no. of patients requiring mechanical ventilation, oxygen therapy and length of stay, mortality, organ status, immunological, biochemical, hematological profile and adverse reactions. | Specific to COVID-19 |
IFN-α | 3 (NCT04320238) ½ (NCT04379518) |
2944 44 |
Recruiting | Onset of COVID-19, clinical signs, viral clearance, viral kinetics, immunological kinetics and adverse effects | Specific |
IFN-β | 4 (NCT04350671) 4 (NCT04350684) 2 (NCT04385095) |
40 40 820 |
Enrolling by invitation Recruiting |
Improvement in clinical signs, mortality, SpO2 improvement, incidence of new mechanical ventilation use, duration of hospitalization, and adverse events, safety and tolerability, progression to pneumonia, viral clearance, blood ad sputum biomarkers. | Specific |
IFN-λ | 2 (NCT04343976) 2 (NCT04388709) 2 (NCT04344600) |
20 66 164 |
Enrolling by invitation Not yet recruiting Recruiting |
COVID PCR testing, symptomatic improvement, improved clinical outcomes, resolution of hypoxia, fever, rate of progression to requiring critical care, overall survival, time to discharge, and adverse events. | Specific |
NK cell | ½ (NCT04344548) | 10 | Not yet recruiting | NK transfer Immunogenicity and adverse events | |
T cell | ½ (NCT04276896) | 100 | Recruiting | Clinical improvement, lung lesions, mortality, duration of mechanical ventilation and hospitalization, RT-PCR testing, inflammatory biomarkers, adverse events. | Specific |
CAR NK cell | ½ (NCT04324996) | 90 | Recruiting | Clinical response and side effects | Not specific |
MSC | 2/3 (NCT04366063) ½ (NCT04346368) ½ (NCT04366323) 1 (NCT04276987) |
60 20 26 24 |
Recruiting Not yet recruiting Recruiting Completed |
Blood oxygen saturation, intensive care unit-free days, clinical symptoms, respiratory efficacy, biomarkers concentrations in plasma, hospital stay, CT scan, changes in viral load, changes of CD4+, CD8+ cells count and concentration of cytokines, C-reactive protein, mortality, adverse events assessment, safety and efficacy of the administration of allogeneic mesenchymal stem cells, duration of stay, mortality | Not specific |
IL-6 blockade | 4 (NCT04377750) 2 (NCT04357808) 2 (NCT04370834) 1 (NCT04386239) |
500 30 217 40 |
Recruiting Active, not recruiting Suspended (pending evaluation of data from other trial) Not yet recruiting |
Survival, clinical status assessment, duration of hospitalization, no. of deaths, improvement of the respiratory function, resolution of fever, viral load on blood and sputum, plasma concentration of GM-CSF, plasma concentration of Il-6, plasma concentration of TNF-α, rate of progression of White Blood Cell (WBC) fraction | Specific |
IL-1 blockade | 2/3 (NCT04324021) 2 (NCT04341584) 2 (NCT04339712) |
54 240 40 |
Recruiting Not yet recruiting Recruiting |
Time to mechanical ventilation, change in total score, oxygen saturation (SpO2), partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2), pH, carbon dioxide tension (pCO2), oxygen tension (pO2) in hemogasanalysis, potassium, sodium, chloride, lactic acid, hemoglobin, oxygen supplementation, ferritin, CT of chest, lactate dehydrogenase (LDH), D-dimers, hemato-biochemicals, immunological biomarkers, viral load, ventilator free-days, change of baseline total sequential organ failure assessment (SOFA) score, survival and time to hospital discharge | Specific |
IFN‐γ blockade | 2/3 (NCT04324021) | 54 | Recruiting | No. of patients not requiring invasive mechanical ventilation or Extracorporeal membrane oxygenation (ECMO), time to mechanical ventilation, Modified Early Warning system score, change in total score, oxygen saturation (SpO2), partial pressure of oxygen/fraction of inspired oxygen (PaO2/FiO2), pH, carbon dioxide tension (pCO2), oxygen tension (pO2) in hemogasanalysis, potassium, sodium, chloride, lactic acid, hemoglobin, oxygen supplementation, ferritin, CT of chest, lactate dehydrogenase (LDH), D-dimers, hemato-biochemicals, immunological biomarkers, viral load, ventilator free-days, change of baseline total sequential organ failure assessment (SOFA) scoresurvival and time to hospital discharge | Specific |
TNF blockade | 2 (NCT04370236) | 366 | Recruiting | Proportion of participants with disease progression, all-cause mortality, who transfer to ICU level care, a new onset of neurologic disease, evidence of new CHF or new MI, new onset embolus or thrombus, develop a need for renal replacement therapy, an increase in the WHO Ordinal Scale of Clinical Improvement score, length of hospital stay and inflammation markers | Specific |