Deprecated: Return type of DrupalCacheArray::offsetExists($offset) should either be compatible with ArrayAccess::offsetExists(mixed $offset): bool, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in /home/rprlib/prod72/www/includes/bootstrap.inc on line 362
Deprecated: Return type of DrupalCacheArray::offsetGet($offset) should either be compatible with ArrayAccess::offsetGet(mixed $offset): mixed, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in /home/rprlib/prod72/www/includes/bootstrap.inc on line 369
Deprecated: Return type of DrupalCacheArray::offsetSet($offset, $value) should either be compatible with ArrayAccess::offsetSet(mixed $offset, mixed $value): void, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in /home/rprlib/prod72/www/includes/bootstrap.inc on line 381
Deprecated: Return type of DrupalCacheArray::offsetUnset($offset) should either be compatible with ArrayAccess::offsetUnset(mixed $offset): void, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in /home/rprlib/prod72/www/includes/bootstrap.inc on line 388 University of Oklahoma Health Sciences Center
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in drupal_environment_initialize() (line 695 of /home/rprlib/prod72/www/includes/bootstrap.inc).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in drupal_environment_initialize() (line 696 of /home/rprlib/prod72/www/includes/bootstrap.inc).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in drupal_environment_initialize() (line 697 of /home/rprlib/prod72/www/includes/bootstrap.inc).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in drupal_environment_initialize() (line 700 of /home/rprlib/prod72/www/includes/bootstrap.inc).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in drupal_environment_initialize() (line 702 of /home/rprlib/prod72/www/includes/bootstrap.inc).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in include_once() (line 328 of /home/rprlib/prod72/www/sites/default/settings.php).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in include_once() (line 329 of /home/rprlib/prod72/www/sites/default/settings.php).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in include_once() (line 337 of /home/rprlib/prod72/www/sites/default/settings.php).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in include_once() (line 344 of /home/rprlib/prod72/www/sites/default/settings.php).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in drupal_settings_initialize() (line 819 of /home/rprlib/prod72/www/includes/bootstrap.inc).
Warning: ini_set(): Session ini settings cannot be changed after headers have already been sent in drupal_settings_initialize() (line 828 of /home/rprlib/prod72/www/includes/bootstrap.inc).
Warning: session_name(): Session name cannot be changed after headers have already been sent in drupal_settings_initialize() (line 831 of /home/rprlib/prod72/www/includes/bootstrap.inc).
Deprecated function: Return type of DatabaseStatementBase::execute($args = [], $options = []) should either be compatible with PDOStatement::execute(?array $params = null): bool, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in require_once() (line 2244 of /home/rprlib/prod72/www/includes/database/database.inc).
Deprecated function: Return type of DatabaseStatementEmpty::current() should either be compatible with Iterator::current(): mixed, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in require_once() (line 2346 of /home/rprlib/prod72/www/includes/database/database.inc).
Deprecated function: Return type of DatabaseStatementEmpty::next() should either be compatible with Iterator::next(): void, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in require_once() (line 2346 of /home/rprlib/prod72/www/includes/database/database.inc).
Deprecated function: Return type of DatabaseStatementEmpty::key() should either be compatible with Iterator::key(): mixed, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in require_once() (line 2346 of /home/rprlib/prod72/www/includes/database/database.inc).
Deprecated function: Return type of DatabaseStatementEmpty::valid() should either be compatible with Iterator::valid(): bool, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in require_once() (line 2346 of /home/rprlib/prod72/www/includes/database/database.inc).
Deprecated function: Return type of DatabaseStatementEmpty::rewind() should either be compatible with Iterator::rewind(): void, or the #[\ReturnTypeWillChange] attribute should be used to temporarily suppress the notice in require_once() (line 2346 of /home/rprlib/prod72/www/includes/database/database.inc).
Background: Recent data suggest that complications and death from coronavirus disease 2019 (Covid-19) may be related to high viral loads.
Methods: In this ongoing, double-blind, phase 1-3 trial involving nonhospitalized patients with Covid-19, we investigated two fully human, neutralizing monoclonal antibodies against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein, used in a combined cocktail (REGN-COV2) to reduce the risk of the emergence of treatment-resistant mutant virus. Patients were randomly assigned (1:1:1) to receive placebo, 2.4 g of REGN-COV2, or 8.0 g of REGN-COV2 and were prospectively characterized at baseline for endogenous immune response against SARS-CoV-2 (serum antibody-positive or serum antibody-negative). Key end points included the time-weighted average change from baseline in viral load from day 1 through day 7 and the percentage of patients with at least one Covid-19-related medically attended visit through day 29. Safety was assessed in all patients.
Results: Data from 275 patients are reported. The least-squares mean difference (combined REGN-COV2 dose groups vs. placebo group) in the time-weighted average change in viral load from day 1 through day 7 was -0.56 log10 copies per milliliter (95% confidence interval [CI], -1.02 to -0.11) among patients who were serum antibody-negative at baseline and -0.41 log10 copies per milliliter (95% CI, -0.71 to -0.10) in the overall trial population. In the overall trial population, 6% of the patients in the placebo group and 3% of the patients in the combined REGN-COV2 dose groups reported at least one medically attended visit; among patients who were serum antibody-negative at baseline, the corresponding percentages were 15% and 6% (difference, -9 percentage points; 95% CI, -29 to 11). The percentages of patients with hypersensitivity reactions, infusion-related reactions, and other adverse events were similar in the combined REGN-COV2 dose groups and the placebo group.
Conclusions: In this interim analysis, the REGN-COV2 antibody cocktail reduced viral load, with a greater effect in patients whose immune response had not yet been initiated or who had a high viral load at baseline. Safety outcomes were similar in the combined REGN-COV2 dose groups and the placebo group.
